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

NCT ID: NCT02528708

Last Updated: 2021-03-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2021-12-31

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.

Conditions

Postpartum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9% saline solution

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).

Group Type: EXPERIMENTAL

fibrinogen concentrate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Placebo

0.9% saline solution

Intervention Type: DRUG

Other Intervention Names

Riastap; saline

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J Paidas, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Other Identifiers

1504015615

Identifier Type: -

Identifier Source: org_study_id