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

Yale University

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Postpartum Hemorrhage

Treatments: Drug: fibrinogen concentrate; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02528708

1504015615

Details and patient eligibility

About

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).

Full 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.

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo

Fibrinogen concentrate

Experimental group

Description:

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).

Treatment:

Drug: fibrinogen concentrate