Thrombosomes® in Acute Thoracic Aortic Dissections

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2024-04-11

Brief Summary

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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).

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Detailed Description

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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

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Thoracic Aortic Dissection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel groups, patients entering in either intervention arm or standard treatment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label treatment. Only statistician performing the data analysis will be blinded

Study Groups

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Thrombosomes®

Thrombosomes® (TBX®) up to 3 doses

Group Type EXPERIMENTAL

Thrombosomes®

Intervention Type BIOLOGICAL

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

Standard platelet concentrate

Standard platelet concentrate up to 3 doses

Group Type ACTIVE_COMPARATOR

Standard platelet concentrate

Intervention Type BIOLOGICAL

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

Interventions

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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).

Intervention Type BIOLOGICAL

Standard platelet concentrate

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

Intervention Type BIOLOGICAL

Other Intervention Names

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TBX® Freeze-dried platelets stPC

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No