PCC and Fibrinogen Compared With FFP in PPH

• Status: Withdrawn
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helsinki University Central Hospital

Criteria

Inclusion Criteria:

Women who have delivered vaginally or by caesarean section with a PPH of 2000 ml (the amount of blood loss: in addition to the suctioned blood, sponges, wraps, swabs, etc. are carefully weighed)

Exclusion Criteria:

Women with a history of bleeding tendency or hepatic or renal insufficiency, or PPH exceeding 3000 ml because in that case the initial need for fibrinogen may be even more