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

August 15, 2022 updated by: Alrijne Ziekenhuis Leiderdorp

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

158

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Known pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deep-frozen platelets
-80°C stored fresh, leukocyte depleted (leukodepleted) platelet concentrates.
Drug: Deep-frozen platelets
Cryopreserved platelets
Other Names:
  • Cryopreserved platelets
Active Comparator: Room-temperature stored platelets
+22°C stored platelets
Drug: Deep-frozen platelets
Cryopreserved platelets
Other Names:
  • Cryopreserved platelets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients that achieved haemostasis and show signs of life.
Time Frame: At six hours
Achieved haemostasis (yes/no) as defined a patient no further require erythrocyte transfusions for two hours;
At six hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to heamostasis in minutes after arrival to the hospital
Time Frame: 24 hours
as defined as the time in minutes from arrival to the moment a patient received no further erythrocyte transfusions for two hours
24 hours
Transfused erythrocyte concentrates (EC) / Red Blood Cells (RBC)
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
Units
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
Transfused plasma
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
Units
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
Transfused platelets
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
Units
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
Fibrinogen administration in grams
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
(grams) including the amount of fibrinogen in plasma
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
Laboratory haemoglobin
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
(mmol/L)
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
Laboratory haematocrit
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
(L/L)
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
Laboratory platelet count
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
(x10^9/L)
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
Coagulation parameter Fibrinogen (clauss)
Time Frame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
(g/L)
0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
Coagulation parameter INR
Time Frame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
International Normalized Ratio
0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
Coagulation parameter aPTT
Time Frame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
(seconds) Viscoelastic testing (ROTEM: measured by viscoelastic testing Extem, Intem, Fibtem, Heptem, Aptem
0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
Coagulation parameter viscoelastic testing rotational tromboelastometry (ROTEM)
Time Frame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
ROTEM Extem
0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
Overall mortality
Time Frame: 24 hours, 30 days
Alive at discharge (yes/no)
24 hours, 30 days
Mortality at Emergency Department
Time Frame: During hospital stay
Alive after Emergency Department (yes/no)
During hospital stay
Mortality after surgey
Time Frame: Emergency Department
Alive after surgery (yes/no)
Emergency Department
Time of death
Time Frame: During hospital stay
hours:minutes
During hospital stay
Hospital length of stay
Time Frame: 24 hours, 30 days
Number of days in hospital after admission (date of discharge minus date of admission to the hospital)
24 hours, 30 days
ICU length of stay
Time Frame: 24 hours, 30 days
24 hours, 30 days
Occurence of transfusion reactions
Time Frame: 24 hours, 30 days
24 hours, 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alrijne Ziekenhuis Leiderdorp

Collaborators

Erasmus Medical Center

Investigators

  • Study Director: Femke Noorman, PhD, Military Blood Bank

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

January 1, 2026

Study Completion (Anticipated)

January 1, 2026

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 15, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAFOD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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