Frozen Platelets in the Treatmentof Traumatic or Vascular Bleeding
NCT ID: NCT05502809
Last Updated: 2023-02-01
Study Results
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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NOT_YET_RECRUITING
PHASE3
158 participants
INTERVENTIONAL
2023-06-01
2026-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Deep-frozen platelets
-80°C stored fresh, leukocyte depleted (leukodepleted) platelet concentrates.
Deep-frozen platelets
Cryopreserved platelets
Room-temperature stored platelets
+22°C stored platelets
Deep-frozen platelets
Cryopreserved platelets
Interventions
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Deep-frozen platelets
Cryopreserved platelets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Alive at hospital presentation
* Requiring massive transfusion including platelets
* Signed (deferred) consent
Exclusion Criteria
12 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Alrijne Ziekenhuis Leiderdorp
NETWORK
Responsible Party
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Principal Investigators
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Femke Noorman, PhD
Role: STUDY_DIRECTOR
Military Blood Bank
Central Contacts
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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.
Other Identifiers
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MAFOD
Identifier Type: -
Identifier Source: org_study_id
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