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

Alrijne Ziekenhuis Leiderdorp

Status and phase: Not yet enrolling; Phase 3

Conditions: Trauma; Bleeding

Treatments: Drug: Deep-frozen platelets

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05502809

MAFOD

Details and patient eligibility

About

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.

Enrollment: 158 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

Deep-frozen platelets

Experimental group

Description:

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

Treatment:

Drug: Deep-frozen platelets

Room-temperature stored platelets

Active Comparator group

Description:

+22°C stored platelets

Treatment:

Drug: Deep-frozen platelets