Thrombosomes® in Acute Thoracic Aortic Dissections (TTAD)

Jakob Stensballe, MD, PhD

Status and phase: Completed; Phase 2

Conditions: Thoracic Aortic Dissection

Treatments: Biological: Thrombosomes®; Biological: Standard platelet concentrate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05771831

H-22061913

Details and patient eligibility

About

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).

Full 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).

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient eligible for emergency surgery on cardiopulmonary bypass pump for acute thoracic aortic dissections
• Age ≥ 18 years

Exclusion criteria

• Documented refusal of blood transfusion
• Aortic dissection due to trauma
• Withdrawal from active therapy
• Known hypersensitivity to TBX: the active substance, any of the excipients
• Pregnancy (non-pregnancy confirmed by patient being postmenopausal (women >55 years of age) or having a negative urine-hCG).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Thrombosomes®

Experimental group

Description:

Thrombosomes® (TBX®) up to 3 doses

Treatment:

Biological: Thrombosomes®

Standard platelet concentrate

Active Comparator group

Description:

Standard platelet concentrate up to 3 doses

Treatment:

Biological: Standard platelet concentrate