NCT05502809

Frozen Platelets in the Treatmentof Traumatic or Vascular Bleeding

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Alrijne Ziekenhuis Leiderdorp · Network
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Deep-frozen platelets	Cryopreserved platelets

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2022-08-16
• Last updated: 2023-02-01