Clinical trial NCT05502809: Frozen Platelets in the Treatmentof Traumatic or Vascular Bleeding
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
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Trauma
Bleeding
Keywords: trauma
resuscitation
platelets
cryopreservation
haemorrhage
Lead sponsor: Alrijne Ziekenhuis Leiderdorp
Sponsor class: NETWORK
Collaborators: name: Erasmus Medical Center
First posted: 2022-08-16
Enrollment: 158
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of patients that achieved haemostasis and show signs of life.
timeFrame: At six hours
Secondary outcomes:
measure: Time to heamostasis in minutes after arrival to the hospital
timeFrame: 24 hours
measure: Transfused erythrocyte concentrates (EC) / Red Blood Cells (RBC)
timeFrame: 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
measure: Transfused plasma
timeFrame: 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
measure: Transfused platelets
timeFrame: 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
measure: Fibrinogen administration in grams
timeFrame: 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
measure: Laboratory haemoglobin
timeFrame: 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
measure: Laboratory haematocrit
timeFrame: 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
measure: Laboratory platelet count
timeFrame: 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
measure: Coagulation parameter Fibrinogen (clauss)
timeFrame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
measure: Coagulation parameter INR
timeFrame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
measure: Coagulation parameter aPTT
timeFrame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
measure: Coagulation parameter viscoelastic testing rotational tromboelastometry (ROTEM)
timeFrame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
measure: Overall mortality
timeFrame: 24 hours, 30 days
measure: Mortality at Emergency Department
timeFrame: During hospital stay
measure: Mortality after surgey
timeFrame: Emergency Department
measure: Time of death
timeFrame: During hospital stay
measure: Hospital length of stay
timeFrame: 24 hours, 30 days
measure: ICU length of stay
timeFrame: 24 hours, 30 days
measure: Occurence of transfusion reactions
timeFrame: 24 hours, 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Military Blood Bank
name: Femke Noorman, PhD
role: STUDY_DIRECTOR
References:
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.