Frozen Platelets in the Treatmentof Traumatic or Vascular Bleeding

NCT05502809 | Unknown Phase 3

• 1 other identifier: MAFOD
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Trauma; Bleeding

Keywords

trauma; resuscitation; platelets; cryopreservation; haemorrhage

Outcome Measures

Primary Outcomes (1)

• 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;

  At six hours

Secondary Outcomes (19)

• Time to heamostasis in minutes after arrival to the hospital

  24 hours

• Transfused erythrocyte concentrates (EC) / Red Blood Cells (RBC)

  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

  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

  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

  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

Study Arms (2)

Deep-frozen platelets

EXPERIMENTAL

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

Drug: Deep-frozen platelets

Room-temperature stored platelets

ACTIVE COMPARATOR

+22°C stored platelets

Drug: Deep-frozen platelets

Interventions

Deep-frozen platelets DRUG

Cryopreserved platelets

Also known as: Cryopreserved platelets

Deep-frozen platelets; Room-temperature stored platelets

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known pregnancy

Sponsors & Collaborators

• Alrijne Ziekenhuis Leiderdorp: lead
• Erasmus Medical Center: collaborator

Related Publications (1)

• 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.

  PMID: 36153539 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Femke Noorman, PhD

  Military Blood Bank

  STUDY DIRECTOR

Central Study Contacts

Tim Rijnhout

CONTACT

0715828282; twhrijnhout@alrijne.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 16, 2022
• Study Start: June 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 1, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share