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

Phase 1

Withdrawn

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Placebo; Drug: fibrinogen concentrate

• Registration Number: NCT02528708
• Lead Sponsor: Yale University

Brief 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.

Study Timeline

• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Study Start: 2021-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-15
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	At the same time of randomization code generation, blood samples for a baseline ROTEM® analysis will be drawn, and blood products will be ordered. Patients will be eligible to receive study drug (fibrinogen concentrate or 0.9% saline solution), according to the randomization code previously generated, only if FIBTEM® - A10 value is \<18 mm (corresponding to a MCF value of \<20 mm, that is a plasma fibrinogen level \<3 g/L).
Fibrinogen concentrate	fibrinogen concentrate	At the same time of randomization code generation, blood samples for a baseline ROTEM® analysis will be drawn, and blood products will be ordered. Patients will be eligible to receive study drug (fibrinogen concentrate or 0.9% saline solution), according to the randomization code previously generated, only if FIBTEM® - A10 value is \<18 mm (corresponding to a MCF value of \<20 mm, that is a plasma fibrinogen level \<3 g/L).

Primary Outcome Measures

Name	Time	Method
maximum clot firmness (MCF via FIBTEM A10)	24 hours	fib-tem® is a ready-to-use ROTEM® system reagent for use with citrated whole blood. It assesses the clot firmness of the fibrin clot. This is influenced mainly by the fibrinogen- and F XIII levels of the blood sample and by fibrin polymerisation disorders. The reagent contains a powerful platelet inhibitor; therefore only a fibrin clot is formed and measured. MCF is measured as the maximal amplitude of the curve.