NCT02528708 - A Program to Evaluate Riastap® and FIBTEM® for the Early Control and Treatment of Postpartum Hemorrhage (PERFECT PPH) | Crick

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Postpartum Hemorrhage

Interventions

fibrinogen concentrateDRUG

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.

PlaceboDRUG

0.9% saline solution

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

maximum clot firmness (MCF via FIBTEM A10)

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.

Time frame: 15 minutes

maximum clot firmness (MCF via FIBTEM A10)

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.

Time frame: 1 hour

maximum clot firmness (MCF via FIBTEM A10)

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.

Time frame: 6 hours

maximum clot firmness (MCF via FIBTEM A10)

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.

Time frame: 24 hours