Clinical Efficacy of Recombinant Activated Factor VII in Management of Postpartum Hemorrhage

Soo Hyeon Moon; Seung Chul Kim; Jong Kil Joo; Dong Soo Suh; Dong Hyung Lee

doi:10.7469/CSD.2013.24.1.29

Journal List > Korean J Perinatol > v.24(1) > 1013693

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Moon, Kim, Joo, Suh, and Lee: Clinical Efficacy of Recombinant Activated Factor VII in Management of Postpartum Hemorrhage

Original Article

Korean J Perinatol 2013;24(1):29-36.

Published online: 19 February 2013

DOI: https://doi.org/10.7469/CSD.2013.24.1.29

Clinical Efficacy of Recombinant Activated Factor VII in Management of Postpartum Hemorrhage

Soo Hyeon Moon, M.D., Seung Chul Kim, M.D., Ph.D.^∗,, Jong Kil Joo, M.D., Ph.D., Dong Soo Suh, M.D., Ph.D., Dong Hyung Lee, M.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.

Received 11 January 2013 Revised 18 March 2013 Accepted 22 March 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.

Abstract

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.

Keywords: Clinical efficacy, Postpartum hemorrhage, Recombinant activated factor VII

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Fig. 1

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

Fig. 2

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

Table 1.

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

Table 2.

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)
No	Dosage of rFVIIa	Response	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)

Table 3.

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)
No	Dosage of rFVIIa	Response	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)

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