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Thrombosomes® in Acute Thoracic Aortic Dissections

NCT05771831 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-05-07

No results posted yet for this study

Summary

The hypothesis is that administration of Thrombosomes® (TBX®) as hemostatic support when terminating the cardiopulmonary bypass (CPB) in patients undergoing emergency surgery for acute thoracic aortic dissection (aTAD) is safe and least as effective when compared to standard Platelet Concentrates (stPC).

Conditions

  • Thoracic Aortic Dissection

Interventions

BIOLOGICAL

Thrombosomes®

The intervention with TBX® is to be administered as an intravenous infusion as hemostatic blood product as part of the Massive Transfusion Protocol (MTP).

BIOLOGICAL

Standard platelet concentrate

The administration of standard platelets is administrated, as part of the Massive Transfusion Protocol (MTP).

Sponsors & Collaborators

  • Cellphire Therapeutics, Inc.

    collaborator INDUSTRY

  • Jakob Stensballe, MD, PhD

    lead OTHER

Principal Investigators

  • Annette Ulrich, MD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2024-04-11
Completion
2024-04-11

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05771831 on ClinicalTrials.gov