kjp Korean Journal of Perinatology Korean J Perinatol 1229-2605 2289-0432 Korean Society of Perinatology 10.7469/CSD.2013.24.1.29 kjp-24-29 Original Article Clinical Efficacy of Recombinant Activated Factor VII in Management of Postpartum Hemorrhage MoonSoo HyeonM.D. KimSeung ChulM.D., Ph.D. ∗ JooJong KilM.D., Ph.D. SuhDong SooM.D., Ph.D. LeeDong HyungM.D., Ph.D. Department of Obstetrics and Gynecology, Pusan National University School of Medicine, Busan, Korea 주관책임자 : 김승철, 602-739 부산시 서구 구덕로 305 부산대학교 의학전문대학원 산부인과학교실 전화 : 051)240-7282, 전송 : 051)248-2384 E-mail : ksch0127@naver.com

∗본 연구는 2011년도 부산대학교병원 임상연구비 지원으로 이루 어졌음.

 22013 1922013 24129 36 11012013 18032013 22032013 Copyright © 2013 Korean Society of Perinatology 2013 This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Purpose :

This study was aimed to investigate the clinical efficacy of recombinant activated factor VII (rFVIIa) for patients with intractable postpartum hemorrhage.

 Methods :

This was a retrospective study of ten patients who were treated with rFVIIa from July 2010 to February 2012 in one tertiary center. To evaluate each case, we used a standardized case record form. The primary outcome measures were response of rFVIIa, reduction of blood product requirement, changes of coagulation parameter. The response of rFVIIa was categorized to three groups: “complete responder”, “partial responder”, “poor responder”.

 Results :

After the administration of rFVIIa, effect for bleeding was completely responded in 4 patients, partially responded in 6 patients, and poorly responded in none. A certain amount of reduction in blood product requirements was noted following rFVIIa administration, although no significant differences were observed statistically between before and after rFVIIa administration except RBC (P<0.01). Fibrinogen and INR were significantly reduced in all case types, but other coagulation parameters were not (P<0.01).

 Conclusion :

The present results suggest that rFVIIa is a beneficial therapeutic option that could reduce blood loss and contribute to reduction of maternal morbidities and mortalities in patients with massive postpartum hemorrhage.

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Comparison of requirement of RBC, FFP and PLT concentrates before (A) and after (B) administration of rFVIIa.

Comparison of aPTT, fibrinogen, INR and platelets level before (A) and after (B) administration of rFVIIa.

Patient Characteristics and Obstetric Data in Parturients Receiving rFVIIa

No Age (years) Parity Gestational age (weeks) Mode of delivery Causes of bleeding Interventions prior to infusion of rFVIIa
1 33 1 37 CD Uterine atony Hysterectomy
2 21 1 39 VD Uterine atony Right UAE
3 37 1 38 CD Uterine vessel injury Both UAE
4 33 1 39 VD Cervical/vaginal laceration Right UAE
5 41 1 29 CD Uterine atony, preeclampsia Intraperitoneal, intrauterine hematoma evacuation
6 27 1 40 VD Uterine vessel injury Bilateral internal iliac artery embolization
7 43 1 35 CD Placenta previa totalis Hysterectomy
8 30 1 39 VD Uterine atony Both UAE
9 39 1 37 VD Uterine atony Both UAE
10 36 2 40 VD Placenta accreta Hysterectomy, gauze packing

Abbreviations: CD, cesarean delivery; VD, vaginal delivery; UAE, uterine artery embolization

Comparison of Blood Products Requirement before and within 24 Hours after Initial rFVIIa Administration

No Dosage of rFVIIa Response RBC (U)∗ FFP (U) PLT concentrates (U)
Before After Before After Before After
1 80 μg/kg Complete 30 0 22 6 14 10
2 80 μg/kg Partial 6 0 6 3 0 0
3 80 μg/kg Complete 25 3 21 6 28 8
4 80 μg/kg Partial 5 7 5 9 0 0
5 80 μg/kg Complete 14 5 8 7 9 6
6 85 μg/kg Partial 13 10 3 15 16 16
7 85 μg/kg Partial 47 12 32 3 24 8
8 85 μg/kg Partial 15 10 17 8 39 23
9 85 μg/kg Partial 24 12 25 15 16 32
10 85 μg/kg Complete 23 2 25 4 18 0
  Median (range)   19 (5-47) 6 (0-12) 19 (3-25) 6.5 (3-15) 16 (0-39) 8 (0-32)

Abbreviations: RBC, red blood cells; FFP, frech frozen plasma; U, unit P values are calculated using Wilcoxon signed rank sum test (∗<0.01 was considered statistically significant)

Comparison of aPTT/INR, Fibrinogen and Platelet Level before and after Initial rFVIIa Administration

No Dosage of rFVIIa Response aPTT (seconds) INR∗ Fibrinogen∗ (mg/dL) Platelet (x103/U)
Before After Before After Before After Before After
1 80 μg/kg Complete 131.4 78.0 10.0 1.79 55.6 50.0 71 101
2 80 μg/kg Partial 180.0 44.9 1.93 0.95 79.7 64.0 70 53
3 80 μg/kg Complete 54.9 42.7 1.31 0.82 120.0 110.0 36 58
4 80 μg/kg Partial 60.8 38.8 1.35 1.26 94.0 80.0 123 82
5 80 μg/kg Complete 61.8 52.8 1.62 1.14 102.0 100.0 85 69
6 85 μg/kg Partial 67.4 51.7 1.50 1.39 107.2 90.0 95 138
7 85 μg/kg Partial 111.6 50.9 1.41 1.20 65.0 60.0 91 93
8 85 μg/kg Partial 69.0 180.0 1.74 1.29 54.0 50.0 79 104
9 85 μg/kg Partial 180.0 180.0 3.50 3.00 150.0 140.0 100 61
10 85 μg/kg Complete 60.0 33.4 1.32 1.01 160.0 138.0 150 85
  Median (range) 68.2 (54.9-180.0) 51.3 (33.4-180.0) 1.56 (1.31-10.0) 1.23 (0.82-3.0) 98.0 (54.0-160.0) 85.0 (50.0-140.0) 86.0 (36.0-150.0) 83.5 (53.0-138.0)

Abbreviations: U, unit; aPTT, activated partial thromboplastin time; INR, International Normalized Ratio P values are calculated using Wilcoxon signed rank sum test (∗<0.01 was considered statistically significant)