CompletedPhase 2

Thrombosomes® in Acute Thoracic Aortic Dissections

Denmark41 participantsStarted 2023-03-15

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Time to hemostasis during surgery

Timeframe: During procedure

Trial details

NCT IDNCT05771831

SponsorJakob Stensballe, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-11

View on ClinicalTrials.gov More Thoracic Aortic Dissection trials