NCT02528708

A Program to Evaluate Riastap® and FIBTEM® for the Early Control and Treatment of Postpartum Hemorrhage (PERFECT PPH)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The proposed trial targets early detection and treatment of fibrinogen depletion in PPH. A widespread belief in the benefits of early fibrinogen substitution in cases of PPH has led to an increased use for this indication. The PERFECT PPH aims to provide an evidence-based knowledge for the recommendation of the early use of fibrinogen concentrate in PPH.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	fibrinogen concentrate	The dose of fibrinogen concentrate needed to achieve this target will be calculated using a formula that accounts for the baseline FIBTEM® - A10 value and the patient's body weight assessed at hospital admission . In general, a 70-kg patient requires a fibrinogen dose of approximately 0.5 g to increase the MCF by approximately 1 mm.
DRUG	Placebo	0.9% saline solution

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2015-08-19
• Last updated: 2021-03-15

Regulatory

• FDA-regulated drug study