Frozen Platelets in the Treatmentof Traumatic or Vascular Bleeding

NCT ID: NCT05502809

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Trauma Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Deep-frozen platelets

-80°C stored fresh, leukocyte depleted (leukodepleted) platelet concentrates.

Group Type EXPERIMENTAL

Deep-frozen platelets

Intervention Type DRUG

Cryopreserved platelets

Room-temperature stored platelets

+22°C stored platelets

Group Type ACTIVE_COMPARATOR

Deep-frozen platelets

Intervention Type DRUG

Cryopreserved platelets

Interventions

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Deep-frozen platelets

Cryopreserved platelets

Intervention Type DRUG

Other Intervention Names

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Cryopreserved platelets

Eligibility Criteria

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Inclusion Criteria

* Patients of 12 years or older
* Alive at hospital presentation
* Requiring massive transfusion including platelets
* Signed (deferred) consent

Exclusion Criteria

* Known pregnancy
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role collaborator

Alrijne Ziekenhuis Leiderdorp

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Femke Noorman, PhD

Role: STUDY_DIRECTOR

Military Blood Bank

Central Contacts

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Tim Rijnhout

Role: CONTACT

0715828282

References

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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.

Reference Type DERIVED
PMID: 36153539 (View on PubMed)

Other Identifiers

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MAFOD

Identifier Type: -

Identifier Source: org_study_id

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