REFERENCES
1. Shander A. Crit Care Med. 2003 Dec;31(12 Suppl):S708-14.
2. Shander A, Moskowitz D, Rijhwani TS. Semin Cardiothorac Vasc Anesth. 2005 Mar;9(1):53-63.
3. Vaislic C, Bical O, Deleuze P, Khoury W, Gaillard D, Ponzio O, Olivier Y, Robine B, Dupuys C, Sportiche M. Arch mal Coeur Vaiss.
2005 Jan;98(1):7-12.
4. Gohel MS, Bulbulia RA, Slim FJ, Poskitt KR, Whyman MR. Ann R Coll Surg Engl. 2005 Jan;87(1):3-14.
5. Madjdpour C, Heindl V, Spahn DR. Minerva Anetesiol. 2006 May;72(5):283-98.
6. Schalte G, Janz H, Busse J, Jovanovic V, Rossaint R, Kuhlen R. Br J Anaesth. 2005 Apr;94(4):442-4.
7. Shander A, Knight K, Thurer R, Adamson J, Spence R. Am J Med. 2004 Apr 5;116 Suppl 7A:58-69.
8. Pieracci FM, Barie PS. Crit Care Med. 2006 May 9; [Epub ahead of print].
9. Venofer® Package Insert 2007 (American Regent Laboratories).
10. Ferrlecit® Package Insert 2007 (Watson Laboratories).
11. InFed® Package Insert 2007 (Watson Laboratories).
IDENTIFYING THE SAFETY OF
LOW MOLECULAR WEIGHT (LMW)
IRON DEXTRAN (InFed®) ADMINISTRATION
IN A BLOOD MANAGEMENT PROGRAM
TREATING VARIOUS DISEASE STATES
12. Dexferrum® Package Insert 2007 (American Regent Laboratories).
13. IV iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia:
A multicenter, open label, randomized trial. Auerbach et al. JCO. 2004;22 (7):1301-1307.
Kirby Sweitzer, MD, FACS1, Katie Simmons, RN1,
Edmund Doherty, Pharm D2, and Melissa Grimm RN, MSN1
1
Mercy Medical Center, Canton, OH;
2
Watson Laboratories, Inc., Morristown, NJ
14. Fletes et al. Am J Kidney Dis. 2001;37:743-749.
15. McCarthy, et al. Am J Neph. 2000;20:455-462.
16. Coyne, et al. Kidney International, Vol 63:2003.
17. Chertow GM et al. Nephrol Dial Transplant. 2004;19:1571-1575.
18. Chertow GM et al. Nephrol Dial Transplant. 2006 Feb;21(2):378-82.
19. AWP Reference - 2007 Redbook.
20. Kalantar-Zadeh et al. Am J Kidney Dis. 1998;1:263-272.
21. Sunder-Plassmann et al. Clin Nephrol. 1997;47:141-157.
ABSTRACT
22. Kalantar-Zadeh et al. Nephrol Dial Transplant. 2004;19:141-149.
Study was sponsored by Watson Pharmaceuticals
Reprints requests: [email protected]
Presented at the SABM 2007 6th Annual Meeting, Hollywood, California, September 7-9, 2007.
Purpose:
A retrospective review of 601 patients enrolled in a blood management program over a five year period was conducted to
assess the safety and efficacy of intravenous (IV) low molecular weight (LMW) iron dextran (InFed®) and to identify predictors
of decreased transfusion requirements by disease state.
Methods:
Notes:
Charts of patients who received erythropoietin agents and/or IV iron as part of the blood management intervention to
prevent the need for blood transfusion since April of 2002 were reviewed. Data collected included admitting diagnosis,
baseline hemoglobin (Hgb), iron indices, units of blood transfused, erythropoietin dose, IV iron dose, length of hospital stay
(LOS) and adverse reactions to IV iron.
Results:
From these 601 patients the most common diagnoses were: urgent surgery, colon cancer, anemia in patients scheduled for
general surgery (gen. surg)/ObGyn, C-section and total abdominal hysterectomy (TAH). A total of 149 patients received
LMW iron (InFed®) and had one serious adverse reaction, 143 patients received high molecular weight (HMW) iron
(Dexferrum®) and had two serious reactions and 169 patients received iron sucrose (Venofer®) and had no serious
reactions. When assessing the patients for predictors of decreased transfusions it was noted that 416 (69%) patients did not
need a transfusion. These patients had a mean pre-operative Hgb of 11.53 g/dl vs. a Hgb of 10.85 g/dl for those patients
who did need transfusions (p=0.001). Patients who were Jehovah’s Witnesses (JW) were excluded from subsequent
analyses and were evaluated separately. In elective surgery patients, those who did not need a transfusion had a mean preoperative Hgb at three to four weeks prior to surgery of 11.2 g/dl vs. a Hgb of 10.4 g/dl for those patients who did need
transfusions (p<0.001). For urgent surgery, patients who did not need a transfusion had a mean baseline Hgb of 12.9 g/dl
vs. a Hgb of 12.1 g/dl for those patients who did need transfusions (p=0.012). The patient transfusion record, iron laboratory
results, iron dosing, baseline Hgb, erythropoietin (EPO) dose and length of stay (LOS) also varied when comparing the
various admitting diagnoses for the elective surgery patients.
Conclusions:
Patient transfusion needs varied based upon diagnosis, iron dosing, iron labs, baseline Hgb and erythropoietin dosing. The
administration of LMW iron dextran in this blood management program is a safe, convenient and cost effective first line
therapy in many patients. The primary advantages would be its relative safety, moderate cost and dosing flexibility. This
institution plans to use this information to further improve disease specific blood management interventions and guidelines.
INTRODUCTION
RESULTS
u A total of 601 patients were included in this analysis.
Elective Surgery*
u There are multiple IV iron preparations available with uniform efficacy but varied safety profiles and dosing profiles.9-18
u Patients were classified as responders to the guideline interventions if
they did not need a blood transfusion at any point in their stay.
u The IV irons are generally categorized as the dextrans (InFed® and Dexferrum®) and the non-dextrans ferric gluconate (Ferrlecit®) and iron sucrose
(Venofer®). In these categories the non-dextrans are normally viewed as the products with fewer adverse reactions while the dextrans, although
labeled for doses of up to 100 mg are often administered in higher doses thus allowing faster iron repletion dosing.9-13
u The overall demographics of the patients did not have any statistical
influence on the patients who were responders (no transfusions) vs.
those who were not responders (transfusions). (Table 1)
Serum Iron - µg/dL
TIBC - µg/dL
TSAT - %
Serum Ferritin - ng/mL
Admitting Hgb - g/dL
Lowest Hgb - g/dL
Total Iron - mg
Total EPO - Units (in 1000s)
LOS - Days
Patients (n)
n PRBC>0
Percent PRBC>0
Avg. PRBC
u The utilization of erythropoietic agents along with intravenous iron has been shown to be an effective approach to decrease the need for blood transfusions.1-8
(InFed®)
u When reviewing the literature, it can be noted that LMW iron dextran
has significantly fewer (2-8 times) adverse reactions than HMW iron
dextran (Dexferrum®).14-18 Our institution subsequently converted from HMW iron dextran to LMW iron dextran, based upon this literature.
u A total of 84 JW patients were treated. These patients were excluded from the
transfusion responder analysis because they cannot receive transfusions.
u This institution reviewed the outcomes of two current interventional blood conservation guidelines. One for urgent surgery using primarily iron
dextran (LMW and HMW) and the second using primarily iron sucrose for elective surgery.
Table 1. Patient Demographics
Admitting Diagnosis
u The focus was on outcomes in terms of avoiding transfusions, decreasing LOS, drug safety and overall cost.
Patients
N (%)
Overall
601
Urgent Surgery
127 (21.1%)
Colon Cancer
46 (7.6%)
General Surgery/ObGyn
46 (7.6%)
TAH
34 (5.7%)
C-Section
22 (3.6%)
OBJECTIVES
To review 5 years utilization of IV iron in a blood conservation program regarding the following:
u Assess the safety of all the IV irons at our institution in elective surgery and urgent surgery patients. This included low molecular weight iron dextran
(InFed®), high molecular weight iron dextran (Dexferrum®) and iron sucrose (Venofer®).
u Assess the efficacy of current interventional guidelines based on hemoglobin, serum iron, transferrin saturation (TSAT), total iron binding capacity
(TIBC), serum ferritin, iron dosing, epoetin alpha dosing, transfusion rates and length of stay (LOS). In addition, we set out to review the outcomes of
the large Jehovah’s Witness (JW) population serviced by this institution.
u Review the cost of treatment with IV iron by iron products.
METHODS
No Transfusion
N (%)
Transfusion
N (%)
416 (69%)
74 (58%)
38 (83%)
34 (74%)
27 (79%)
14 (64%)
185 (31%)
53 (42%)
8 (17%)
12 (36%)
7 (21%)
8 (36%)
Gender
Female
Male
420 (69.9%)
181 (30%)
302 (72%)
115 (64%)
118 (28%)
66 (36%)
Race
White
Black
Asian
Other
508 (84.5%)
81 (13.5%)
4 (0.7%)
8 (1.3%)
345 (68%)
63 (78%)
4 (100%)
4 (50%)
163 (32%)
18 (22%)
0 (0%)
4 (50%)
Jehovah Witness
Yes
No
84 (13.9%)
517 (86.0%)
84 (100%)
332 (64%)
0 (0%)
185 (36%)
53.1
50.9
58.0
Age
Mean
Design
Data Collection
Retrospective chart and registry review of patients treated within
the last 5 years with erythropoietin agents and/or IV iron by our
current blood conservation guidelines.
Patient charts and laboratory data were reviewed retrospectively to assess the
safety and effectiveness of each patient’s iron regimen. The following data were
collected from each patient:
EFFICACY AND PREDICTORS OF DECREASED TRANSFUSIONS
Inclusion Criteria
u Hgb levels at time of admission, lowest Hgb and weekly post-op for 4-6 weeks
– In elective surgery, admission Hgb was taken 3-4 weeks prior to surgery
and in urgent surgery immediately prior to surgery
Part of the purpose of this analysis was to assess the efficacy of the two
guidelines and possibly to identify predictors of response. A response was
defined as no need for a transfusion.
u Iron indices: Serum Iron, TSAT, TIBC, and serum ferritin
– In elective surgery, admission iron values were drawn 3-4 weeks prior to surgery
– In urgent surgery iron studies were drawn prior to the surgical procedure in
order to avoid misleading iron values if the patient received a blood
transfusion during the surgery and to maintain blood draws to a minimum
It should be noted that according to the American Society of
Anesthesiologists Task Force: Transfusions are rarely indicated when a
patient’s hemoglobin is >10 g/dl and almost always indicated when the
hemoglobin is less than 6 g/dl. Transfusing between 6 and 10 g/dl is a
decision based upon the patient’s physiology, signs and symptoms.
All patients enrolled, screened and treated via blood conservation
guidelines and evaluated by an RN trained in blood conservation.
Exclusion Criteria
Patients who are referred to the program have no exclusion
criteria from enrollment however, patients are not given iron
dextran products in order to decrease the likelihood of adverse
reaction (as per Package Insert) if they have a history of the
following:
u Total cumulative amount of IV iron
u This hospital has a defined transfusion trigger of 7.0 g/dl and this is used
for quality improvement purposes.
u Total amount of Erythropoietin Stimulating Agent (ESA) administered,
erythropoietin alpha (Procrit®) (EPO)
Urgent Surgery Patients (Table 2)
u Rheumatoid arthritis
u Number of transfusions administered at anytime during the stay
– This hospital has a defined transfusion trigger of 7.0 g/dl and this is used
for quality improvement purposes
u Hepatic impairment
u Length of hospital stay
u Asthma (broncho spasm)
u Serious adverse reactions to IV iron
u Age, sex, ethnicity, surgical procedure/service
For all patients included in this analysis the surgical procedures were classified as either an urgent surgery or elective surgery. Patients identified for
urgent surgery were treated via the guideline in Figure 1 and the patients identified for elective surgery were treated via the guideline in Figure 2.
Figure 1. Urgent Surgery Guideline
Figure 2. Elective Surgery Guideline
Lab work
Iron panel (Iron, TIBC, iron saturation) and ferritin
CBC
Lab work
Iron panel (Iron, TIBC, iron saturation) and ferritin
CBC
Sat < 20% or
Ferritin < 100
Surgery
Hgb < 11
Sat < 20% or
Ferritin < 100
Calculate iron
requirements1,2
Allergy/Cl to
Iron Dextran3
Yes
Sat 21-49% or
Ferritin 101-799
FeSO4 325mg po bid
MVI po qd
Folic acid 1mg po qd
Vitamin C 500mg po qd
If TPN, add InFed 50mg,
MVI, Folic Acid
Calculate iron
requirements1,2
Sat > 50% or
Ferritin > 800
No Iron
MVI po qd
Folic acid 1mg
po qd
No
Venofer up to 300mg5,6
Repeat qod until reach
iron requirements
MVI po qd
Folic acid 1mg po qd
InFed up to 1000mg4,6
Benadryl 50mg IV
Solumedrol 40mg IV
Repeat qweek until
reach iron requirements
MVI po qd
Folic acid 1mg po qd
Allergy/Cl to Iron3
Dextran or coming in
qweek for epogen
300mg5,6
Venofer up to
Repeat qod until reach
iron requirements
MVI po qd
Folic acid 1mg po qd
Sat 21-49% or
Ferritin 101-799
FeSO4 325mg po bid
MVI po qd
Folic acid 1mg po qd
Vitamin C 500mg po qd
Sat > 50% or
Ferritin > 800
No Iron
MVI po qd
Folic acid 1mg
po qd
No allergy/Cl to Iron
Dextran and doing
EPO at home
1000mg4,6
InFed up to
Benadryl 50mg IV
Solumedrol 40mg IV
MVI po qd
Folic acid 1mg po qd
> 21 days EPO 600 units/kg
SC/IV qweek x 3 weeks and day of
surgery
< 21 days EPO 300 units/kg
SC/IV qd x 10d prior to surgery,
the day of surgery, and
for four days after
If Hgb 8.1 to 10.9 then
EPO 600 units/kg qweek until Hgb > 11
If Hgb < 8.0
EPO 300 units/kg three times weekly
until Hgb > 8.1, then follow above dosing
Round to nearest 10,000
1. Total iron (mg) = [0.0442 (Des Hgb—Obs Hgb) x LBW + (0.26 x LBW) ] x 50
2. LBW (men) = 50kg + 2.3 x #in > 60 in / women = 45.5kg + 2.3 x #in > 60 in
3. Contraindications to InFed: Asthma, hepatic impairment, rheumatoid arthritis
u The first review was of patients who utilized the Urgent Surgery Guideline.
u These results showed that the patients who did not receive any
transfusions had statistically lower serum iron values (p=0.026), higher
TIBC values (p=0.008), lower TSATs (p=0.015), and lower serum ferritins
(p=0.01). In addition, they had higher admitting Hgb's (p=0.013), lower
iron doses (NS) and lower EPO doses (p<0.001).
u Patients who never required any transfusions had a significantly shorter
LOS of 7.7 days vs. 14.1 days (p<0.001).
Dosing and Administration
u Overall, 53 out of 123 patients received some blood transfusions (43%).
One of the limitations is that for this group transfusions could not be
broken out into surgical and post-surgical. This will need to be reviewed
in a future analysis.
Table 2.
Urgent Surgery*
Serum Iron - µg/dL
TIBC - µg/dL
TSAT - %
Serum Ferritin - ng/mL
Admitting Hgb - g/dL
Lowest Hgb - g/dL
Total Iron - mg
Total EPO - Units (in 1000s)
LOS - Days
Patients (n)
n PRBC>0
Percent PRBC>0
Avg. PRBC
PHARMACOECONOMICS
Table 3a.
No Trans
STD
Trans
STD
P Value
27.31
279.00
10.34
194.85
12.92
9.58
628.57
22.40
7.73
123.00
53.00
43.09
2.53
16.40
76.68
6.62
211.96
1.71
1.34
493.18
31.84
5.07
40.83
242.98
16.42
343.19
12.09
7.88
686.79
36.51
14.06
46.44
70.12
18.80
409.44
1.87
0.86
621.73
44.18
11.30
0.026
0.009
0.015
0.013
0.012
<0.001
0.564
0.042
<0.001
1.40
*No JW patients included.
Elective Surgery Patients (Table 3a)
u Initially an analysis was done to assess the success of our elective
surgery guideline in terms of decreased blood transfusions. This was a
general overview excluding JW.
u There were 394 patients and 132 (33.5%) required transfusions.
u The most common diagnoses were colon cancer, anemia prior to elective
surgery (general/ObGyn), total abdominal hysterectomy and C-section.
u Patients who did not require transfusions had a higher TIBC (p<0.001), a
lower serum ferritin (p<0.001), a higher admitting Hgb (p<0.001), and a
lower total EPO dose (p=0.002).
u Overall the responders experienced a much shorter LOS: 5.6 days vs.
15.3 for those who received transfusions (p<0.001).
Jehovah’s Witness Surgery Patients (Table 5a)
No Trans
STD
Trans
STD
P Value
43.25
325.40
14.02
143.04
11.24
9.09
711.49
47.18
5.57
394.00
132.00
33.50
3.56
50.84
137.92
14.27
232.41
2.13
1.54
544.41
66.02
6.01
37.61
267.17
14.41
280.96
10.35
7.64
643.19
72.05
15.33
50.25
119.35
15.46
380.97
2.31
1.36
587.90
90.75
14.67
0.302
<0.001
0.811
<0.001
<0.001
<0.001
0.254
0.002
<0.001
u There were a total of 84 JW patients in this analysis. Since JW patients cannot
receive blood transfusion they could not be used in the primary analyses of the
two blood conservation iron guidelines. However, to better assess our specific
treatment of this patient population and our elective surgery guideline in meeting
their needs, their outcomes were compared to the 262 non-JW elective surgery
patients who did not require transfusions.
u The JW patients received more EPO and IV iron but only the EPO dose was
statistically significant (p<0.001).
u The JW patients also had higher serum ferritins and a longer LOS (p=0.011).
Table 5a.
Elective
Surgery
3.58
*No JW and no transfusions.
Elective Surgery Patients (Table 3b)
u This same group was then analyzed to compare the outcome of patients who
received IV iron vs. those who did not.
u A total of 322 patients received IV iron while 72 did not. The IV iron group received
fewer transfusions compared to the no IV iron group (31% vs. 42%, p=0.116) and
required fewer PRBC (p=0.018).
u All the IV iron patients had significantly lower iron measures.
u The patients who received IV iron received more EPO (p=0.002).
Table 3b.
Elective Surgery*
IV Iron
STD
No IV Iron
STD
P Value
Serum Iron - µg/dL
TIBC - µg/dL
TSAT - %
Serum Ferritin - ng/mL
Admitting Hgb - g/dL
Lowest Hgb - g/dL
Total Iron - mg
Total EPO - Units (in 1000s)
LOS - Days
Patients (n)
n PRBC>0
Percent PRBC>0
Avg. PRBC
38.97
313.21
12.32
148.30
10.90
8.56
840.38
61.28
8.81
322.00
102.00
31.00
1.05
51.89
134.83
12.93
219.45
2.32
1.65
504.38
78.48
11.01
52.82
268.76
23.18
384.64
10.98
8.67
0.00
30.14
9.10
72.00
30.00
42.00
1.87
43.15
128.93
18.91
489.55
1.87
1.55
0.00
57.85
10.02
0.043
0.017
<0.001
<0.001
0.803
0.633
2.43
0.002
0.838
Serum Iron - µg/dL
TIBC - µg/dL
TSAT - %
Serum Ferritin - ng/mL
Admitting Hgb - g/dL
Lowest Hgb - g/dL
Total Iron - mg
Total EPO - Units (in 1000s)
LOS - Days
Patients (n)
n PRBC>0
0.018
*No JW patients included.
The next analysis was of the top four admitting diagnoses for patients who under went
elective surgery (colon cancer, general surgery/ObGyn, total abdominal hysterectomy
[TAH] and C-section) (Table 4).
Colon Cancer
u Twelve of the 43 (28%) patients required a blood transfusion at some point.
u These patients were more likely to avoid transfusion if they had a higher admitting Hgb of
11.7 g/dl vs. 9.7 g/dl (p=0.005).
u In addition, those patients who required transfusions had a longer LOS of 16 days vs.
8.5 days (p=0.007) vs. those who did not.
Total Abdominal Hysterectomy (TAH)
u This group consisted of 30 patients, of which 7 (23%) required a blood transfusion.
u The patients who did not require a transfusion had a higher TIBC (p=0.003).
u Admitting Hgb was not a predictor of transfusions in these patients (p=0.851).
u Patients receiving transfusions also required a longer LOS of 10.1 days vs. 2.4 days (p=0.002).
General Surgery/ObGyn
u Patients who were admitted to the program with anemia prior to surgery for primarily
general surgical/ObGyn procedures were grouped together due to the primary diagnosis of
anemia. Anemia was generally defined as a Hgb <12 g/dl.
u Forty-two patients fit this category and 8 (19%) required blood transfusions.
u The primary differences were a lower serum ferritin in those who did not need a
transfusion (p=0.007) and higher total iron dose (p=0.001).
u The patients who received transfusions also had a longer LOS (p<0.001).
C-Section
u This group had 20 patients and 8 (40%) patients required a blood transfusion.
u Admitting Hgb was not a predictor of transfusions in these patients (p=0.386).
u Patients who did not require transfusions had higher TIBC values (p=0.010) and larger
IV iron doses (p=0.006).
STD
43.23
310.03
15.86
222.56
11.13
8.72
854.38
87.31
7.89
80.00
0.00
33.41
109.71
14.71
289.80
2.80
2.17
732.01
96.69
9.99
43.25
325.40
14.02
143.04
11.24
9.09
711.49
47.18
5.57
262.00
0.00
STD
P Value
50.84
137.92
14.27
232.41
2.13
1.54
544.41
66.02
6.01
0.997
0.378
0.346
0.018
0.714
0.102
0.060
<0.001
0.011
Notes: n corresponds to sample sizes; the table is based on those getting PRBC=0; JW n=80;
Non-JW (no transfusions) n=262; 4 trauma patients for JW were removed from original 84 to correlate with
the removal of the Non-JW trauma patients being removed.
Jehovah’s Witness Elective Surgery Patients (Table 5b)
u The second analysis of the JW population looked at the 80 patients who received
elective surgery specifically.
u The 63 patients receiving iron had an average iron dose of approximately a gram
(1085 mg).
The AWP of iron sucrose is
somewhat higher than iron
dextran but is a viable
alternative to give on an
outpatient basis. For our
facility the choice is ultimately
up to the patients. If the
patient wants to receive the
complete iron dose all at once
they can spend a day at the
infusion center for iron dextran
or they can come to the
infusion center multiple times
to receive iron sucrose on an
outpatient basis until the
desired total is achieved. A
table of the cost of a gram for
all 3 products is listed in
Figure 3.
When reviewing the total
amount of iron given in this
period, 423.9 grams of IV iron
were administered. From this
119.3 grams were iron sucrose
and 304.6 grams were iron
dextran. Had all the patients
received LMW iron dextran the
cost for drug would result in a
decrease
of
$37,077.03
(Figure 4).
u In addition, they had significantly higher EPO doses (p<0.001).
Table 5b.
Serum Iron - µg/dL
TIBC - µg/dL
TSAT - %
Serum Ferritin - ng/mL
Admitting Hgb - g/dL
Lowest Hgb - g/dL
Total Iron - mg
Total EPO - Units (in 1000s)
LOS - Days
Patients (n)
IV Iron
STD
35.87
309.87
13.51
220.15
10.79
8.27
1084.92
105.89
9.02
63.00
25.46
116.67
12.91
276.06
2.85
2.03
654.68
99.19
10.85
No
IV Iron
78.31
310.77
28.45
234.42
12.61
10.87
0.00
18.47
3.71
17.00
STD
P Value
44.44
70.90
17.86
363.93
2.03
1.48
0.00
40.56
3.58
<0.001
0.979
0.001
0.878
0.027
<0.001
0.001
0.051
SAFETY
When analyzing the safety of these products all three IV iron preparations were reviewed.
In this time period 143 received HMW iron dextran, 149 patients received LMW iron
dextran and 169 received iron sucrose. The patients were reviewed for reports of
serious reactions as defined by the MedWatch post-marketing safety categories.
There were 2 serious reactions with HMW iron dextran, one reaction with the LMW
iron dextran and none with the iron sucrose. Although our analysis had too few
patients to determine drug safety, based on the published literature and our personal
experience, our formulary was modified to include only LMW iron dextran and iron
sucrose. The necessity of higher dosing for urgent surgeries warrants at least one
iron dextran as an option along with a non dextran iron.
No Trans
Serum Iron - µg/dL
30.52
TIBC - µg/dL
282.96
TSAT - %
10.92
Serum Ferritin - ng/mL
109.37
Admitting Hgb - g/dL
11.68
Lowest Hgb - g/dL
9.30
Total Iron - mg
1046.77
Total EPO - Units (in 1000s) 85.48
LOS - Days
8.48
Patients (n)
43.00
n PRBC>0
12.00
Percent PRBC>0
27.91
Avg. PRBC
2.75
$687.50
$700
$600
$500
$377.00
$400
$377.00
$300
$200
$100
$0
Dexferrum® InFed®
Venofer®
Reference: 2007 Redbook
Figure 4. Dollars
$250,000
$200,000 $196,887.30
$159,810.30
$150,000
$100,000
$50,000
$37,077.03
Total Iron Total Iron Potential
Costs
Costs
Savings
Only InFed®
As always, if a patient has a sensitivity to iron dextran the alternative non-dextran
would still be the drug of choice. It should also be noted that the average
cumulative iron sucrose dose was approximately 500 mg while the cumulative
iron dextran dose averaged over 1000 mg.
DISCUSSION
The benefits of LMW intravenous iron dextran (InFed®) are primarily the cost and
the potential for higher doses in surgery patients, especially urgent surgery
patients. In addition, the safety profile of LMW iron dextran is more favorable
compared to HMW iron dextran and may be closer to the non-dextrans than
previously presumed.17-18
The primary impact of our intervention methodology can be seen in the decrease
in patient LOS in patients not receiving transfusions (Figure 5). These results of
responders to our guidelines will result in a re-evaluation of the steps based upon
outcomes and predictors of response. We will address issues such as which irons
are given to which admitting diagnosis as well as how much and what iron values
should be utilized to make the decision to administer IV iron.
As we look at each lab we need to remember the limitations in each. For
example, serum ferritin is a non-specific acute phase reactant in addition to being
a marker of iron stores. Also, TIBC can be negatively affected by malnutrition and
inflammation and in turn affect TSAT.20-22
Overall, our program is very successful. However, we will continue to improve our
process. A few points we are planning to review and possibly modify include:
u Are TSAT and ferritin alone enough to make a quality iron intervention?
u Should we increase the TSAT value for IV iron administration?
u Do patients with a lower serum ferritin respond better in some cases because
the guideline is designed to give them more iron? Should we increase the
ferritin value for IV iron administration?
u Do we need more diagnosis specific guidelines for elective surgery or JW
patients based upon this experience?
u Also, we plan to assess our referral process for elective surgeries in the hope of
increasing the overall baseline Hgb levels and/or referral time prior to surgery
with the hope of increasing the rate of responders (non-transfused) and
decreasing blood transfusions and the overall LOS.
Figure 5. Transfusion Related Average Length of Stay
20.00
Table 4.
Colon Cancer*
TAH*
General Surgery/ObGyn*†
C-Section*
STD
Trans
STD P Value No Trans STD Trans STD P Value No Trans STD
Trans
STD P Value No Trans STD
Trans
STD P Value
29.14
61.75 115.33 0.163
77.29
91.37 58.71 63.49 0.624
33.18
34.42
44.63 69.11 0.498
62.08
64.33
26.14
9.70
0.165
113.00 293.13 116.04 0.827 392.38
88.44 265.14 87.92 0.003 456.68 118.37 415.00 105.01 0.367 498.58 105.28 364.71
81.75
0.010
12.25
11.00
9.68 0.987
19.95
21.80 21.00 24.13 0.915
8.03
8.59
15.88 29.94 0.184
12.58
13.05
7.29
3.25
0.311
103.60 151.18 202.71 0.404
17.11
13.89 39.67 42.87 0.057
23.37
36.48 303.40 539.58 0.007
21.82
40.47
30.00
27.86
0.667
1.84
9.68
2.29 0.005
10.83
1.79 10.66
2.84 0.851
8.46
1.43
8.09
3.06 0.750
10.34
1.81
10.98
1.07
0.387
1.45
7.83
1.47 0.005
9.86
1.64
7.14
0.84 <0.001
8.52
1.43
7.29
3.02 0.126
8.70
1.83
6.31
1.48
0.006
588.92 1070.83 731.89 0.911 689.13 429.58 557.29 435.13 0.484 748.53 350.86 262.50 333.54 0.001 500.00 346.41 250.00 169.03
0.076
105.57 112.67 125.89 0.477
57.39
53.70 34.29 42.76 0.308
53.53
68.00
22.50 36.15 0.222
32.50
28.64
45.00
45.04
0.456
5.03
16.00 12.60 0.007
2.43
0.59 10.14 11.38 0.002
0.38
0.82
4.63
3.66 <0.001
4.42
2.78
8.88
9.01
0.122
30.00
42.00
20.00
7.00
8.00
8.00
23.33
19.05
2.63
40.00
2.05
2.57
1.27
0.92
5.25
5.85
Figure 3. AWP/Gram
$800
$0
u The patients receiving iron had significantly lower iron values, lower admitting
hemoglobin and longer LOS.
JW Elective
Surgery
3.50
JW
Non-JW
(No Trans)
When selecting an IV iron preparation, safety, cost, dosing, specific interventions
and patient needs must all be considered. HMW and LMW iron dextran have the
same average wholesale price (AWP). Since LMW iron dextran has a more
favorable safety profile than HMW iron dextran at the same cost, we selected
LMW iron dextran as our preferred iron dextran product.
No transfusion
Transfusion
15.00
Days
PATIENT DISPOSITION AND CHARACTERISTICS
u Development of a blood conservation program has been shown to be both beneficial to the patients as well as to the cost of overall care.1-8
10.00
5.00
0.00
*No JW patients included; †Anemic patients for general surgery, ObGyn, etc.
Urgent
Surgery
Elective General Colon
Surgery Surgery/ Cancer
ObGyn
Procedure
TAH
C-Section
CONCLUSIONS
4. Give 25mg test dose over 30 min, observe 30 min, then remaining over 6 hr
5. Give 25mg test dose over 30 min, observe 30 min, then remaining over 2 hr
6. Recheck iron: if 1000mg then 14d after dose; < 1000mg then 7d after dose
Statistics
u Evaluable population: All patients who were enrolled in the blood conservation program and received at least one treatment with erythropoietin
alpha (Procrit®) and/or intravenous iron.
u Safety population: All patients who received an IV iron preparation were assessed for serious adverse reactions from patient charts and registry.
u Statistical significance was calculated using a two-sample t-test between patients getting a transfusion and those getting no transfusions. In
addition, elective surgery and JW patients who were receiving IV iron vs. those who were not were compared. Differences were considered
significant if the P value <0.05. A P value of <0.01 was considered highly significant.
u Mercy Medical’s current blood management experience has validated that LMW iron dextran is a safe and convenient IV iron alternative when utilized
appropriately.
u LMW iron dextran provides flexible dosing and a cost benefit compared to the non-dextran preparations.
u Mercy Medical’s current blood management guidelines have been shown to effectively decrease patient’s hospital LOS.
u These guidelines will need to be modified to improve the outcomes shown here.
u The possibility of more patient specific guidelines is also under review. Regarding the Elective Surgery Guideline we will initially focus on the JW and
Colon Cancer patients.
u The blood management team will use these findings to further improve the results seen here both therapeutically and financially.