Thrombosomes® in Acute Thoracic Aortic Dissections

NCT05771831 | Completed Phase 2

• 1 other identifier: H-22061913
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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).

Conditions

Thoracic Aortic Dissection

Keywords

Surgery; Bleeding

Outcome Measures

Primary Outcomes (1)

• Time to hemostasis during surgery

  Defined by initiation of chest closure (temporary or final closure), the placement of the first sternal wire or wound vac (ioban or film), from administration of full dose protamine.

  During procedure

Secondary Outcomes (19)

• Bleeding during surgery

  During procedure

• Bleeding in chest tubes and mediastinal drainages on arrival in the ICU

  Average 3 hours

• Bleeding in mL in chest tube and mediastinal drainage at 24 hour after arrival in the ICU

  24 hours

• Bleeding in mL/kg in chest tube and mediastinal drainage at 24 hour after arrival in the ICU

  24 hours

• Total number of blood product use during surgery

  During procedure

Study Arms (2)

Thrombosomes®

EXPERIMENTAL

Thrombosomes® (TBX®) up to 3 doses

Biological: Thrombosomes®

Standard platelet concentrate

ACTIVE COMPARATOR

Standard platelet concentrate up to 3 doses

Biological: Standard platelet concentrate

Interventions

Thrombosomes® 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).

Also known as: TBX®, Freeze-dried platelets

Thrombosomes®

Standard platelet concentrate BIOLOGICAL

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

Also known as: stPC

Standard platelet concentrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jakob Stensballe, MD, PhD: lead
• Cellphire Therapeutics, Inc.: collaborator

Study Sites (1)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Dissection, Thoracic Aorta; Hemorrhage

Condition Hierarchy (Ancestors)

Aortic Dissection; Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Annette Ulrich, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label treatment. Only statistician performing the data analysis will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of research

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

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 16, 2023
• Study Start: March 15, 2023
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)