drugset / Trial / NCT01910675
PCC and Fibrinogen Compared With FFP in PPH
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
Publications
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.