Clinical trial NCT05771831: Thrombosomes® in Acute Thoracic Aortic Dissections
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thoracic Aortic Dissection
Keywords: Surgery
Bleeding
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Cellphire Therapeutics, Inc.
First posted: 2023-03-16
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel groups, patients entering in either intervention arm or standard treatment
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Time to hemostasis during surgery
timeFrame: During procedure
Secondary outcomes:
measure: Bleeding during surgery
timeFrame: During procedure
measure: Bleeding in chest tubes and mediastinal drainages on arrival in the ICU
timeFrame: Average 3 hours
measure: Bleeding in mL in chest tube and mediastinal drainage at 24 hour after arrival in the ICU
timeFrame: 24 hours
measure: Bleeding in mL/kg in chest tube and mediastinal drainage at 24 hour after arrival in the ICU
timeFrame: 24 hours
measure: Total number of blood product use during surgery
timeFrame: During procedure
measure: Total volume of blood product use during surgery
timeFrame: During procedure
measure: Total number of blood product use during the first 24 hours in the ICU
timeFrame: 24 hours
measure: Total units of blood product use during the first 24 hours in the ICU
timeFrame: 24 hours
measure: Number of patients needing re-do surgery due to hemorrhage
timeFrame: 24 hours
measure: Sequential Organ Failure Assessment (SOFA) score during stay in ICU within 12 days
timeFrame: 12 days
measure: Hemostatic product use during surgery
timeFrame: During procedure
measure: Vasopressor free days within 30 days
timeFrame: 30 days
measure: Ventilator free days
timeFrame: 30 days
measure: Renal replacement free days
timeFrame: 30 days
measure: Length of stay in ICU
timeFrame: 30 days
measure: Length of stay in hospital
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: Symptomatic thrombo-embolic events
timeFrame: 30 days
measure: Serious adverse reactions/events
timeFrame: 12 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen University Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Annette Ulrich, MD
role: PRINCIPAL_INVESTIGATOR
References: