drugset / Trial / NCT02528708
A Program to Evaluate Riastap® and FIBTEM® for the Early Control and Treatment of Postpartum Hemorrhage (PERFECT PPH)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
In this prospective, single-center, randomized, placebo-controlled, double-blind clinical trial, parturients with primary PPH are eligible for treatment with fibrinogen concentrate following both vaginal delivery and cesarean section complicated by an estimated blood loss (EBL) \>1000 mL and an ongoing bleeding notwithstanding standard treatment measures (volume replacement, uterine massage, and uterotonic agents).
Timeline
- Start
- 2021-01
- Primary completion
- 2021-12
- Completion
- 2021-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fibrinogen Concentrate Human | Protein / enzyme biologic | 0.5 g | — |
Indications
No indication recorded.