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Frozen Platelets in the Treatmentof Traumatic or Vascular Bleeding (MAFOD)

Primary Purpose

Trauma, Bleeding

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Deep-frozen platelets
Sponsored by
Alrijne Ziekenhuis Leiderdorp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring trauma, resuscitation, platelets, cryopreservation, haemorrhage

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients of 12 years or older
  • Alive at hospital presentation
  • Requiring massive transfusion including platelets
  • Signed (deferred) consent

Exclusion Criteria:

  • Known pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Deep-frozen platelets

    Room-temperature stored platelets

    Arm Description

    -80°C stored fresh, leukocyte depleted (leukodepleted) platelet concentrates.

    +22°C stored platelets

    Outcomes

    Primary Outcome Measures

    Percentage of patients that achieved haemostasis and show signs of life.
    Achieved haemostasis (yes/no) as defined a patient no further require erythrocyte transfusions for two hours;

    Secondary Outcome Measures

    Time to heamostasis in minutes after arrival to the hospital
    as defined as the time in minutes from arrival to the moment a patient received no further erythrocyte transfusions for two hours
    Transfused erythrocyte concentrates (EC) / Red Blood Cells (RBC)
    Units
    Transfused plasma
    Units
    Transfused platelets
    Units
    Fibrinogen administration in grams
    (grams) including the amount of fibrinogen in plasma
    Laboratory haemoglobin
    (mmol/L)
    Laboratory haematocrit
    (L/L)
    Laboratory platelet count
    (x10^9/L)
    Coagulation parameter Fibrinogen (clauss)
    (g/L)
    Coagulation parameter INR
    International Normalized Ratio
    Coagulation parameter aPTT
    (seconds) Viscoelastic testing (ROTEM: measured by viscoelastic testing Extem, Intem, Fibtem, Heptem, Aptem
    Coagulation parameter viscoelastic testing rotational tromboelastometry (ROTEM)
    ROTEM Extem
    Overall mortality
    Alive at discharge (yes/no)
    Mortality at Emergency Department
    Alive after Emergency Department (yes/no)
    Mortality after surgey
    Alive after surgery (yes/no)
    Time of death
    hours:minutes
    Hospital length of stay
    Number of days in hospital after admission (date of discharge minus date of admission to the hospital)
    ICU length of stay
    Occurence of transfusion reactions

    Full Information

    First Posted
    August 1, 2022
    Last Updated
    January 31, 2023
    Sponsor
    Alrijne Ziekenhuis Leiderdorp
    Collaborators
    Erasmus Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05502809
    Brief Title
    Frozen Platelets in the Treatmentof Traumatic or Vascular Bleeding
    Acronym
    MAFOD
    Official Title
    The Haemostatic Effect of Deep-frozen Platelets Versus Room Temperature Stored Platelets in the Treatment of Traumatic or Vascular Bleeding. MAFOD: a Randomized Controlled Non-inferiority Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2026 (Anticipated)
    Study Completion Date
    January 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alrijne Ziekenhuis Leiderdorp
    Collaborators
    Erasmus Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Primarily due to its logistical advantages The Netherlands Armed Forces (NLAF) have been successfully using deep frozen (-80°C) platelets (DTC) for the treatment of (massive) bleeding trauma patients in austere environments since 2001. However, high-quality evidence for effectiveness and safety in the treatment of these type of patients is currently lacking. The MAssive transfusion of Frozen bloOD (MAFOD) trial is therefore designed to compare the haemostatic effect of DTCs versus room temperature stored platelets (RSP) in the treatment of trauma- and vascular bleeding.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Trauma, Bleeding
    Keywords
    trauma, resuscitation, platelets, cryopreservation, haemorrhage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    158 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Deep-frozen platelets
    Arm Type
    Experimental
    Arm Description
    -80°C stored fresh, leukocyte depleted (leukodepleted) platelet concentrates.
    Arm Title
    Room-temperature stored platelets
    Arm Type
    Active Comparator
    Arm Description
    +22°C stored platelets
    Intervention Type
    Drug
    Intervention Name(s)
    Deep-frozen platelets
    Other Intervention Name(s)
    Cryopreserved platelets
    Intervention Description
    Cryopreserved platelets
    Primary Outcome Measure Information:
    Title
    Percentage of patients that achieved haemostasis and show signs of life.
    Description
    Achieved haemostasis (yes/no) as defined a patient no further require erythrocyte transfusions for two hours;
    Time Frame
    At six hours
    Secondary Outcome Measure Information:
    Title
    Time to heamostasis in minutes after arrival to the hospital
    Description
    as defined as the time in minutes from arrival to the moment a patient received no further erythrocyte transfusions for two hours
    Time Frame
    24 hours
    Title
    Transfused erythrocyte concentrates (EC) / Red Blood Cells (RBC)
    Description
    Units
    Time Frame
    Measurement in 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
    Title
    Transfused plasma
    Description
    Units
    Time Frame
    Measurement in 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
    Title
    Transfused platelets
    Description
    Units
    Time Frame
    Measurement in 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
    Title
    Fibrinogen administration in grams
    Description
    (grams) including the amount of fibrinogen in plasma
    Time Frame
    0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
    Title
    Laboratory haemoglobin
    Description
    (mmol/L)
    Time Frame
    0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
    Title
    Laboratory haematocrit
    Description
    (L/L)
    Time Frame
    0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
    Title
    Laboratory platelet count
    Description
    (x10^9/L)
    Time Frame
    0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge
    Title
    Coagulation parameter Fibrinogen (clauss)
    Description
    (g/L)
    Time Frame
    0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
    Title
    Coagulation parameter INR
    Description
    International Normalized Ratio
    Time Frame
    0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
    Title
    Coagulation parameter aPTT
    Description
    (seconds) Viscoelastic testing (ROTEM: measured by viscoelastic testing Extem, Intem, Fibtem, Heptem, Aptem
    Time Frame
    0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
    Title
    Coagulation parameter viscoelastic testing rotational tromboelastometry (ROTEM)
    Description
    ROTEM Extem
    Time Frame
    0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
    Title
    Overall mortality
    Description
    Alive at discharge (yes/no)
    Time Frame
    24 hours, 30 days
    Title
    Mortality at Emergency Department
    Description
    Alive after Emergency Department (yes/no)
    Time Frame
    During hospital stay
    Title
    Mortality after surgey
    Description
    Alive after surgery (yes/no)
    Time Frame
    Emergency Department
    Title
    Time of death
    Description
    hours:minutes
    Time Frame
    During hospital stay
    Title
    Hospital length of stay
    Description
    Number of days in hospital after admission (date of discharge minus date of admission to the hospital)
    Time Frame
    24 hours, 30 days
    Title
    ICU length of stay
    Time Frame
    24 hours, 30 days
    Title
    Occurence of transfusion reactions
    Time Frame
    24 hours, 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients of 12 years or older Alive at hospital presentation Requiring massive transfusion including platelets Signed (deferred) consent Exclusion Criteria: Known pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tim Rijnhout
    Phone
    0715828282
    Email
    twhrijnhout@alrijne.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Femke Noorman, PhD
    Organizational Affiliation
    Military Blood Bank
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    36153539
    Citation
    Rijnhout TWH, Noorman F, van der Horst RA, Tan ECTH, Viersen VVA, van Waes OJF, van de Watering LMG, van der Burg BLSB, Zwaginga JJ, Verhofstad MHJ, Hoencamp R. The haemostatic effect of deep-frozen platelets versus room temperature-stored platelets in the treatment of surgical bleeding: MAFOD-study protocol for a randomized controlled non-inferiority trial. Trials. 2022 Sep 24;23(1):803. doi: 10.1186/s13063-022-06739-2.
    Results Reference
    derived

    Learn more about this trial

    Frozen Platelets in the Treatmentof Traumatic or Vascular Bleeding

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