NCT05771831

Thrombosomes® in Acute Thoracic Aortic Dissections

Feasibility and Safety of Thrombosomes® on Time to Hemostasis in Patients Undergoing Emergency Surgery for Thoracic Aortic Dissections - a Randomized, Controlled, Open-label Investigator-initiated Pilot Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Jakob Stensballe, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study is designed as an exploratory phase 2a, single-center randomized, controlled pilot investigator-initiated trial of administration of Thrombosomes® (TBX®) versus standard platelet concentrates (stPC) in 20 aTAD patients per arm. The patients will be enrolled in the study over a period of 15 months. TBX® is a novel, human platelet (thrombocyte) derived lyophilized (freeze dried) hemostatic blood product for treatment of bleeding due to thrombocytopenia, dysfunctional platelet disorders or platelet consumption. The patients will be randomized to administration of either TBX®, or stPC, as part of the Massive Transfusion Protocol (MTP) at the time of termination of the cardiopulmonary bypass (CPB) in addition to standard goal-directed hemostatic optimization based on results from thrombelastography (TEG).

Conditions

• Thoracic Aortic Dissection

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-03-15
• Primary completion: 2024-04-11
• Completion: 2024-04-11
• First posted: 2023-03-16
• Last updated: 2024-05-07

Locations

1 site across 1 country: Denmark