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

NCT02528708 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 1504015615
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Postpartum Hemorrhage

Keywords

fibrinogen concentrate; coagulation

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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).

Drug: Placebo

Fibrinogen concentrate

EXPERIMENTAL

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).

Drug: fibrinogen concentrate

Interventions

fibrinogen concentrate 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.

Also known as: Riastap

Fibrinogen concentrate

Placebo DRUG

0.9% saline solution

Also known as: saline

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• CSL Behring: collaborator

MeSH Terms

Conditions

Postpartum Hemorrhage; Thrombosis

Interventions

Fibrinogen; Sodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Michael J Paidas, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 19, 2015
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 15, 2021

Record last verified: 2021-03