The haemostatic effect of thawed deep-frozen platelets resuspended in thawed plasma versus room temperature stored platelets in platelet additive solution in the treatment of surgical bleeding; a randomized controlled non-inferiority trial

The haemostatic effect of thawed deep-frozen platelets resuspended in thawed plasma versus room temperature stored platelets in platelet additive solution in the treatment of surgical bleeding; a randomized controlled non-inferiority trial - MAFOD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57248

Enrollment

158

Registered

2021-07-06

Start date

2022-11-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Massaal bloedverlies ten gevolge van traumatisch letsel Massive haemorrhage

Interventions

transfusion with thawed deep-frozen platelets re-suspended in thawed deep-frozen plasma or transfusion with room temperature stored platelets in platelet additive solution in the first 48 hours afte

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients of 12 years or older* 2. Alive at hospital presentation 3. Order of massive transfusion package including platelet concentrate for surgical bleeding (e.g. traumatic bleeding or bleeding in transplantation surgery) 4. Signed deferred consent by patient, proxy, or parents, as applicable. * it is imaginable that the exact age of a child at presentation on the emergency department is not known. At a confirmed age younger than 12, the patient will be excluded from analysis.

Exclusion criteria

Exclusion criteria: - Refusal of blood product administration (e.g. confirmed prior to randomisation in the electronic patient file that patient is a Jehovah*s Witness) - Known pregnancy - Known to refuse resuscitation

Design outcomes

Primary

Measure	Time frame
Primary outcome is the percentage of patients achieved haemostasis at six hours (360 minutes) (as defined as the time in minutes from MTP activation to the moment a patient received no further blood product transfusions for two hours).	—

Secondary

Measure	Time frame
The secondary aims are - Time to haemostasis (as defined as the time in minutes from MTP activation to the moment a patient received no further blood product transfusions for two hours) - Total in-hospital blood component consumption (units) - Fibrinogen administration (including blood component content) - Laboratory parameters (e.g. platelet count, Haematocrit) - Coagulation parameters (INR, fibrinogen levels, ROTEM® parameters). - Mortality - Hospital lenght of stay - Intensive care lenght of stay - Transfusion reactions	—

Measure

Time frame

The secondary aims are - Time to haemostasis (as defined as the time in minutes from MTP activation to the moment a patient received no further blood product transfusions for two hours) - Total in-hospital blood component consumption (units) - Fibrinogen administration (including blood component content) - Laboratory parameters (e.g. platelet count, Haematocrit) - Coagulation parameters (INR, fibrinogen levels, ROTEM® parameters). - Mortality - Hospital lenght of stay - Intensive care lenght of stay - Transfusion reactions

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)