Anest. intenziv. Med. 2010;21(5):229-238

Recombinant activated factor VII (rFVIIa) in the treatment of life threatening post-partum haemorrhage - data from the UniSeven clinical registry in the Czech RepublicIntensive Care Medicine - Original Paper

Seidlová Dagmar^1,*, Blatný Jan², Penka Miroslav², Ovesná Petra⁴, Brabec Petr⁴, Ševčík Pavel¹, Ventruba Pavel⁵, Černý Vladimír³

¹ Klinika anesteziologie, resuscitace a intenzivní medicíny a Anesteziologicko-resuscitační oddělení FN Brno LF MU Brno

² Oddělení klinické hematologie FN Brno, LF MU Brno

³ Klinika anesteziologie, resuscitace a intenzivní medicíny FN Hradec Králové

⁴ Institut biostatistiky a analýz Lékařské a Přírodovědecké fakulty MU Brno

⁵ Gynekologicko-porodnická klinika FN Brno, LF MU Brno

Objective:
To analyze the data related to the treatment of 80 Czech patients with life threatening post-partum haemorrhage recorded in the UniSeven clinical registry in years 2004-2009.

Design:
Retrospective, observational, multicentre study.


Setting:
The ICUs and Obstetrics Departments of university and regional hospitals in the Czech Republic.

Materials and methods:
UniSeven is an international academic project of Masaryk University in Brno, Czech Republic, focused on the recording of clinical data related to the "off-label" use of rFVIIa (Novo Seven) in life threatening bleeding. Data from 80 case reports of post-partum haemorrhage from the registry was analyzed from the clinical (efficacy and safety) and laboratory prospectives.

Results:
In 97.5 % of the patients the treatment with rFVIIa achieved control of the bleeding. In 53 women (66.3%) a single dose of rFVIIa was sufficient to control the bleeding. The rest of the patients received two or more rFVIIa doses. The first dose of rFVIIa given to the patients who needed more than one dose was significantly lower (96.6 µg/kg) compared to patients succesfully treated with a single dose (110.6 µg/kg; p = 0.048). The mortality rate in our cohort of patients was 2.5 %. We did not record any thrombo-embolic events related to the rFVIIa treatment. In the 74.3 % of patients where rFVIIa was administered before considering hysterectomy it was possible to avoid hysterectomy which we consider to be a significant improvement of the patients' quality of life.

Conclusions:
Our data were considered during the preparation of the national guidelines for the treatment of life threatening post-partum haemorrhage in the Czech Republic.

Keywords: post-partum haemorrhage; hysterectomy; rFVIIa; clinical registry

Received: March 17, 2010; Accepted: July 6, 2010; Published: October 1, 2010  Show citation