Authors' results and conclusions: The first stage of article selection produced a total of 431 works (419 MEDLINE and EMBASE articles, 3 documents in the Cochrane Library, 7 reports of other Health Technology Evaluation Agencies and 2 clinical practice guidelines). Due to their titles or summaries 335 were rejected and 96 were selected for the reading of their complete text, which were grouped based on the aetiology of the bleeding. Finally the critical evaluation was made of 27 works, of which 17 were systematic reviews of the literature (SRL) of which 4 were accompanied by recommendations from experts. The remaining 6 were controlled clinical trials (CCTs) not included in the systematic reviews which studied the effectiveness and the safety of rFVIIa as a prophylactic or therapeutic treatment in serious haemorrhages secondary to different aetiologies. Also, 4 case series were included which approached a special clinical situation: bleeding which could not be controlled even after applying all possible therapeutic resources; these desperate clinical situations are called Last-Ditch by some authors. Of the 17 systematic reviews, 7 dealt with bleeding in a general manner, independently of the origin of the haemorrhage; 3 articles had bleeding in cardiac surgery as the study objective, of those, 1 carried experts’ recommendation; 2 works approached bleeding as a result of a major surgery, one also included urological surgery; 2 articles in the context of haematological pathology; 1 article on hepatic diseases; 1 article dealt with primary intracerebral haemorrhage and 1 article, identified in the update of the bibliography, approached severe postpartum haemorrhage. In general, in all the works evaluated, the result variables analysed were the reduction or cessation of bleeding, the transfusion requirements, the necessary dose of rFVIIa and the possible adverse effects and mortality related to the drug. The methodological quality of the reviews was average, in general, and was determined by the type of studies which included few SRL that were based on CCTs, although the methodological quality of these CCTs was average to high. The four works that considered Last-Ditch situations as study objectives were all articles of low methodological quality and with the limitations inherent to the type of study (case series). The survey was suitably completed by all the experts who responded to 100% of the presented scenarios. The responses were concordant with the findings of the review except in the section on acute non-traumatic cerebral haemorrhage

Authors' recommendations: There is no scientific evidence of sufficient quality that supports the indiscriminate use of rFVIIa in severe bleeding in non-haemophiliac patients. The administration of this product must be made on a case by-case basis according to the needs of each patient and the advice of the specialists in charge. To be effective, theadministration of rFVIIa requires that some biological parameters are within, or close to, the normal range (temperature, acid-base status), together with the administration of other haemostatic and haemo-derived drugs that totally, or partially, corrects the coagulopathy present in many of the serious haemorrhages. There is no consensus on the optimal dose-response relationship on the clinical effect of rFVIIa. No significant increase in adverse venous thrombotic events related to the administration of rFVIIa has been described, but a greater number of arterial thrombotic events exist. The agreement described between the opinion of the experts and the conclusions reached in the systematic review, eliminated the need to make a panel with RAND methodology.

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/uso-adecuado-del-factor-vii-activado-recombinante-en-pacientes-no-hemofilicos/

Year Published: 2009

URL for published report: https://www.aetsa.org/download/publicaciones/antiguas/AETSA_2007-04_FactorVII.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: Andalusian Agency for Health Technology Assessment (AETSA)