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

Postpartum Hemorrhage Clinical Trial

— PERFECT PPH  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02528708
• Other study ID #: 1504015615
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: January 2021
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• 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.
• Placebo
0.9% saline solution

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	CSL Behring

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 minutes
Primary	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.	1 hour
Primary	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.	6 hours
Primary	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.	24 hours