drugset / Trial / NCT01910675

PCC and Fibrinogen Compared With FFP in PPH

NCT01910675

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to find out if the regimen of prothrombin complex concentrate (PCC) together with fibrinogen concentrate is as efficient as fresh frozen plasma (FFP) (plus fibrinogen if needed) during the early stages of the transfusion therapy in postpartum haemorrhage (PPH). The original protocol included the use of HES and the recruitment of patients was postponed while waiting the final decision by EMA. All HES solutions were abandoned at our institution in September and an amendment was made to change the protocol. HES solution are replaced by the use of hyperoncotic (20%) albumin.

Timeline

Start
2013-07
Primary completion
2018-10
Completion
2018-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Fibrinogen Concentrate Human Protein / enzyme biologic 2 g
Comparator Octaplas LG Other / unclassified 4 unknown
Subject Octaplex Protein / enzyme biologic 15 iu/kg

Indications

No indication recorded.