bsp; 0
Injection Site Hematoma 3/274 (1.1) NA 2/69 (2.9) 7/69 (10.1)
1 Warfarin sodium dosage was adjusted to maintain a prothrombin time index of 1.4 to 1.5, corresponding to an International Normalized Ratio (INR) of approximately 2.5.
2 Includes three treated patients who did not undergo a surgical procedure.
3 A bleeding event was considered major if: 1) hemorrhage caused a significant clinical event, 2) it was associated with a hemoglobin decrease of ≥2 g/dL or transfusion of 2 or more units of blood products, 3) it resulted in reoperation due to bleeding, or 4) it involved retroperitoneal or intracranial hemorrhage.
4 Includes two treated patients who did not undergo a surgical procedure.
5 Occurred at a rate of at least 2% in the group treated with FRAGMIN 5000 IU once daily.
Six of the patients treated with FRAGMIN experienced seven major bleeding reactions. Two of the reactions were wound hematoma (one requiring reoperation), three were bleeding from the operative site, one was intraoperative bleeding due to vessel damage, and one was gastrointestinal bleeding. None of the patients experienced retroperitoneal or intracranial hemorrhage or died of bleeding compl
In the third hip replacement surgery clinical trial, the incidence of major bleeding reactions was similar in all three treatment groups: 3.6% (18/496) for patients who started FRAGMIN before surgery; 2.5% (12/487) for patients who started FRAGMIN after surgery; and 3.1% (15/489) for patients treated with warfarin sodium.
Abdominal Surgery
Table 7 summarizes bleeding reactions that occurred in clinical trials which studied FRAGMIN 2500 and 5000 IU administered once daily to abdominal surgery patients.
Table 7
Bleeding Reactions Following Abdominal Surgery
Indication FRAGMIN vs Placebo FRAGMIN vs FRAGMIN
Dosing Regimen Dosing Regimen
Abdominal
Surgery FRAGMIN
2500 IU
once
daily subcutaneous
n (%) Placebo
once daily
subcutaneous
n (%) FRAGMIN
2500 IU
once
daily subcutaneous
n (%) FRAGMIN
5000 IU
once
daily subcutaneous
n (%)
Postoperative
Transfusions 14/182
(7.7) 13/182
(7.1) 89/1025
(8.7) 125/1033
(12.1)
Wound
Hematoma 2/79
(2.5) 2/77
(2.6) 1/1030
(0.1) 4/1039
(0.4)
Reoperation
Due to Bleeding 1/79
(1.3) 1/78
(1.3) 2/1030
(0.2) 13/1038
(1.3)
Injection Site
Hematoma 8/172
(4.7) 2/174
(1.1) 36/1026
(3.5) 57/1035
(5.5)
Indication FRAGMIN vs Heparin
Dosing Regimen
Abdominal
Surgery FRAGMIN
2500 IU
once
daily subcu |
