Status:
WITHDRAWN
PCC and Fibrinogen Compared With FFP in PPH
Lead Sponsor:
Helsinki University Central Hospital
Conditions:
Postpartum Haemorrhage
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief 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 ne...
Detailed Description
Forty patients are randomized to receive either PCC and fibrinogen concentrate (PCC group) or FFP (and fibrinogen if needed) (FFP group), 20 patients in each group. Patients in the PCC group receive 1...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01910675
Start Date
July 1 2013
End Date
October 1 2018
Last Update
October 10 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maternity Hospital, Helsinki University Central Hospital
Helsinki, Uusimaa, Finland, FI-00610