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Table 4 Case series on the treatment of severe bleeding with rFVIIa in patients undergoing abdominal surgery without known pre-existing coagulopathy

From: Recombinant activated factor VIIa for the treatment of bleeding in major abdominal surgery including vascular and urological surgery: a review and meta-analysis of published data

Reference(s)

Total number of cases

Patients undergoing abdominal surgery without known pre-existing coagulopathy

rFVIIa dose

Reduction or cessation of bleeding after rFVIIa

Survivors

  

Number

Indication for rFVIIa

   

O'Connell et al. [11] (2003) and Laffan et al. [34] (2005)

40

11

Severe bleeding in patients undergoing colectomy (n = 4), operation of aortic aneurysm (n = 3), splenectomy (n = 2), intestinal resection (n = 1), resection of pseudocyst of pancreas (n = 1)

No information about subgroup

10/11

Not reported

Clark et al. [9] (2004)

10

4

Uncontrollable bleeding and after more than 15 packed red blood cells in elective operation of abdominal aortic aneurysm (n = 3) and after prostatectomy (n = 1)

1 × 7.2 mg (n = 3: 90, 101, and 97 μg/kg)

2 × 7.2 mg (90 μg/kg)

1/4

0/4

Mayo et al. [15] (2004)

13

4

Uncontrollable, life-threatening bleeding after operation of pancreas carcinoma (n = 2) or gastric carcinoma (n = 1) and cholecystectomy (n = 1)

Protocol: 7.2 mg (67.5 to 90 μg/kg), up to two more doses of 2.4 mg

3/4

3/4

Aggarwal et al. [18] (2004)

40

1

Uncontrollable bleeding in a patient with colectomy

2 × 90 μg/kg

0/1

0/1

Manning et al. [10] (2005)

8

6

Uncontrollable bleeding in vascular surgery interventions: aortic aneurysm (n = 5) and infected aortic prosthesis (n = 1)

1 × 40 μg/kg (n = 4)

2 × 40 μg/kg (n = 2)

5/6

4/6

Vilstrup et al. [26] (2006)

11

1

Intraoperative bleeding during operation of peptic duodenal ulcer

1 × 33.3 μg/kg

1/1

1/1

Haas et al. [25] (2005)

5

2

Uncontrollable bleeding in patients with ruptured venous malformation (n = 1) and after laparoscopic cholecystectomy (n = 1)

1) 1 × 120 μg/kg

2) 1 × 80 μg/kg

2/2

2/2

Filan et al. [29] (2005)

4

4

Uncontrollable liver bleeding in premature infants with laparotomy due to necrotizing enterocolitis (n = 4)

1) 2 × 100 μg/kg

2) 1 × 90 μg/kg

3) 2 × 300 μg/kg

4) 2 × 400 μg/kg

3/4

2/4

Biss et al. [12] (2006)

36

8

Uncontrollable bleeding in surgical patients with abdominal aortic aneurysm (n = 4), splenectomy (n = 2), ischemic bowel (n = 1), liver hematoma postcholecystectomy (n = 1)

3 × 30 μg/kg (n = 1)

1 × 90 μg/kg (n = 3)

2 × 90 μg/kg (n = 2)

3 × 90 μg/kg (n = 1)

5 × 90 μg/kg (n = 1)

5/8

2/8

Grounds et al. [13] (2006)

45

9

Intra- or postoperative bleeding in surgical patients with resection of sigma, liver hemangioma, liver rupture, prostatectomy, kidney transplantation, ileocolic anastomosis, endoscopic retrograde cholangiopancreaticography, morbid obesity, duodenopancreatectomy

No detailed information about subgroup

9/9

6/9

Total

212

50

  

39/50

20/39

Estimated mean effect

    

73.2% (51.0%–95.4%)

53.0% (26.4%–79.7%)

  1. rFVIIa, recombinant activated factor VII