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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
158
Cryopreserved platelets
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;
Time frame: At six hours
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
Time frame: 24 hours
Transfused erythrocyte concentrates (EC) / Red Blood Cells (RBC)
Units
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
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Laboratory haematocrit
(L/L)
Time frame: 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)
Time frame: 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)
Time frame: 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
Coagulation parameter INR
International Normalized Ratio
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 24 hours, 30 days
Mortality at Emergency Department
Alive after Emergency Department (yes/no)
Time frame: During hospital stay
Mortality after surgey
Alive after surgery (yes/no)
Time frame: Emergency Department
Time of death
hours:minutes
Time frame: During hospital stay
Hospital length of stay
Number of days in hospital after admission (date of discharge minus date of admission to the hospital)
Time frame: 24 hours, 30 days
ICU length of stay
Time frame: 24 hours, 30 days
Occurence of transfusion reactions
Time frame: 24 hours, 30 days