MAFOD: Frozen Platelets in the Treatmentof Traumatic or Vascular Bleeding
Study Details
Study Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Deep-frozen platelets -80°C stored fresh, leukocyte depleted (leukodepleted) platelet concentrates. |
Drug: Deep-frozen platelets
Cryopreserved platelets
Other Names:
|
| Active Comparator: Room-temperature stored platelets +22°C stored platelets |
Drug: Deep-frozen platelets
Cryopreserved platelets
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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
- 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
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Alrijne Ziekenhuis Leiderdorp
- Erasmus Medical Center
Investigators
- Study Director: Femke Noorman, PhD, Military Blood Bank
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MAFOD