Frozen Platelets in the Treatmentof Traumatic or Vascular Bleeding

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Trauma, Bleeding

Intervention / Treatment
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* Drug: Deep-frozen platelets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of 12 years or older Alive at hospital presentation Requiring massive transfusion including platelets Signed (deferred) consent Exclusion Criteria: Known pregnancy

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep-frozen platelets<br>-80°C stored fresh, leukocyte depleted (leukodepleted) platelet concentrates. | Drug: Deep-frozen platelets<br>* Cryopreserved platelets<br>* Other names: Cryopreserved platelets;|
| Active Comparator: Room-temperature stored platelets<br>+22°C stored platelets | Drug: Deep-frozen platelets<br>* Cryopreserved platelets<br>* Other names: Cryopreserved platelets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to heamostasis in minutes after arrival to the hospital | 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) | 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 | 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 | 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 | (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 | (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 | (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 | (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) | (g/L) | 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours | 
| Coagulation parameter INR | International Normalized Ratio | 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours | 
| Coagulation parameter aPTT | (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) | ROTEM Extem | 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours | 
| Overall mortality | Alive at discharge (yes/no) | 24 hours, 30 days | 
| Mortality at Emergency Department | Alive after Emergency Department (yes/no) | During hospital stay | 
| Mortality after surgey | Alive after surgery (yes/no) | Emergency Department | 
| Time of death | hours:minutes | During hospital stay | 
| Hospital length of stay | 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 |  | 24 hours, 30 days | 
| Occurence of transfusion reactions |  | 24 hours, 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trauma, resuscitation, platelets, cryopreservation, haemorrhage