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

• Status: Withdrawn
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: CSL Behring

Criteria

Inclusion Criteria:

• Informed consent from participant

• Age ≥18 years and <50 years

• Primary PPH defined as bleeding from uterus and/or the birth canal within 24 hours postpartum

• Vaginal delivery or Cesarean delivery (irrespective of etiology of PPH, such as accreta), with EBL >1000 mL and ongoing bleeding notwithstanding standard treatment measures (volume replacement, uterine massage, uterotonic agents)

• FIBTEM®- A10 <18 mm (corresponding to a MCF value of <20 mm and to a plasma fibrinogen level approximately <3 g/L)

Exclusion Criteria:

• Refusal to give written informed consent

• Refusal to receive blood transfusion

• Known inherited deficiencies of coagulation

• Personal history of thrombosis

• Either pre-pregnancy or ante-partum antithrombotic treatment due to increased risk of thrombosis

• Administration of Platelets, FFP or cryotherapy prior to study drug