Frozen Platelets in the Treatmentof Traumatic or Vascular Bleeding

Trauma Clinical Trial

— MAFOD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05502809
• Other study ID #: MAFOD
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: August 2022
• Source: Alrijne Ziekenhuis Leiderdorp
• Contact: Tim Rijnhout
• Phone: 0715828282
• Email: twhrijnhout[@]alrijne.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 158
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Patients of 12 years or older

• Alive at hospital presentation

• Requiring massive transfusion including platelets

• Signed (deferred) consent

Exclusion Criteria:

• Known pregnancy

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Trauma

Intervention

Drug:
• Deep-frozen platelets
Cryopreserved platelets

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alrijne Ziekenhuis Leiderdorp	Erasmus Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Coagulation parameter Fibrinogen (clauss)	(g/L)	0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
Secondary	Coagulation parameter INR	International Normalized Ratio	0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours
Secondary	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
Secondary	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
Secondary	Overall mortality	Alive at discharge (yes/no)	24 hours, 30 days
Secondary	Mortality at Emergency Department	Alive after Emergency Department (yes/no)	During hospital stay
Secondary	Mortality after surgey	Alive after surgery (yes/no)	Emergency Department
Secondary	Time of death	hours:minutes	During hospital stay
Secondary	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
Secondary	ICU length of stay		24 hours, 30 days
Secondary	Occurence of transfusion reactions		24 hours, 30 days