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

Primary Purpose

Postpartum Hemorrhage

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
fibrinogen concentrate
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring fibrinogen concentrate, coagulation

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Fibrinogen concentrate

    Arm 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).

    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).

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 18, 2015
    Last Updated
    March 10, 2021
    Sponsor
    Yale University
    Collaborators
    CSL Behring
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02528708
    Brief Title
    A Program to Evaluate Riastap® and FIBTEM® for the Early Control and Treatment of Postpartum Hemorrhage (PERFECT PPH)
    Acronym
    PERFECT PPH
    Official Title
    A Program to Evaluate Riastap® and FIBTEM® for the Early Control and Treatment of Postpartum Hemorrhage (PERFECT PPH)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study never began.
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University
    Collaborators
    CSL Behring

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postpartum Hemorrhage
    Keywords
    fibrinogen concentrate, coagulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm 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).
    Arm Title
    Fibrinogen concentrate
    Arm Type
    Experimental
    Arm 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).
    Intervention Type
    Drug
    Intervention Name(s)
    fibrinogen concentrate
    Other Intervention Name(s)
    Riastap
    Intervention Description
    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
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    saline
    Intervention Description
    0.9% saline solution
    Primary Outcome Measure Information:
    Title
    maximum clot firmness (MCF via FIBTEM A10)
    Description
    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
    Title
    maximum clot firmness (MCF via FIBTEM A10)
    Description
    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
    Title
    maximum clot firmness (MCF via FIBTEM A10)
    Description
    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
    Title
    maximum clot firmness (MCF via FIBTEM A10)
    Description
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael J Paidas, MD
    Organizational Affiliation
    Yale School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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