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| Name | Class |
|---|---|
| Erasmus Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep-frozen platelets | Experimental | -80°C stored fresh, leukocyte depleted (leukodepleted) platelet concentrates. |
|
| Room-temperature stored platelets | Active Comparator | +22°C stored platelets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep-frozen platelets | Drug | Cryopreserved platelets |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tim Rijnhout | Contact | 0715828282 | twhrijnhout@alrijne.nl |
| Name | Affiliation | Role |
|---|---|---|
| Femke Noorman, PhD | Military Blood Bank | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36153539 | Derived | 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. |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |