Bleeding, Trauma
Conditions
Keywords
trauma, resuscitation, platelets, cryopreservation, haemorrhage
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.
Interventions
DRUGDeep-frozen platelets
Cryopreserved platelets
Sponsors
Erasmus Medical Center
Alrijne Ziekenhuis Leiderdorp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of 12 years or older * Alive at hospital presentation * Requiring massive transfusion including platelets * Signed (deferred) consent
Exclusion criteria
* Known pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients that achieved haemostasis and show signs of life. | At six hours | Achieved haemostasis (yes/no) as defined a patient no further require erythrocyte transfusions for two hours; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transfused erythrocyte concentrates (EC) / Red Blood Cells (RBC) | 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 | Units |
| Transfused plasma | 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 | Units |
| Transfused platelets | 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 | Units |
| Fibrinogen administration in grams | 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 | (grams) including the amount of fibrinogen in plasma |
| Laboratory haemoglobin | 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 | (mmol/L) |
| Laboratory haematocrit | 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 | (L/L) |
| Laboratory platelet count | 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 | (x10\^9/L) |
| Coagulation parameter Fibrinogen (clauss) | 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours | (g/L) |
| Coagulation parameter INR | 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours | International Normalized Ratio |
| Time to heamostasis in minutes after arrival to the hospital | 24 hours | as defined as the time in minutes from arrival to the moment a patient received no further erythrocyte transfusions for two hours |
| Coagulation parameter viscoelastic testing rotational tromboelastometry (ROTEM) | 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours | ROTEM Extem |
| Overall mortality | 24 hours, 30 days | Alive at discharge (yes/no) |
| Mortality at Emergency Department | During hospital stay | Alive after Emergency Department (yes/no) |
| Mortality after surgey | Emergency Department | Alive after surgery (yes/no) |
| Time of death | During hospital stay | hours:minutes |
| Hospital length of stay | 24 hours, 30 days | Number of days in hospital after admission (date of discharge minus date of admission to the hospital) |
| ICU length of stay | 24 hours, 30 days | — |
| Occurence of transfusion reactions | 24 hours, 30 days | — |
| Coagulation parameter aPTT | 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours | (seconds) Viscoelastic testing (ROTEM: measured by viscoelastic testing Extem, Intem, Fibtem, Heptem, Aptem |
Contacts
Primary ContactTim Rijnhout
Outcome results
None listed