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Completed

NCT Number: NCT05771831

Thrombosomes® in Acute Thoracic Aortic Dissections

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

Other names: TBX®, Freeze-dried platelets

Standard platelet concentrate

Biological

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

Other names: stPC

Primary outcomes

  1. Time to hemostasis during surgery

    Time frame: During procedure

    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.

Secondary outcomes

  1. Bleeding during surgery

    Time frame: During procedure

    Bleeding during surgery as measured by suction, cell salvage, chest tubes, mediastinal drains, extracorporeal circulation (ECC), and in the field of surgery

  2. Bleeding in chest tubes and mediastinal drainages on arrival in the ICU

    Time frame: Average 3 hours

    Volume of bleeding in chest tubes and mediastinal drains from end of surgery to arrival in the Intensive Care Unit (ICU)

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

    Time frame: 24 hours

    Volume of bleeding in chest tubes and mediastinal drainages from arrival in the ICU to 24 hours after ICU arrival, measured in mL

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

    Time frame: 24 hours

    Volume of bleeding in chest tubes and mediastinal drainages from arrival in the ICU to 24 hours after ICU arrival, measured in mL/kg

  5. Total number of blood product use during surgery

    Time frame: During procedure

    Number of blood products (RBC, fresh-frozen plasma (FFP), standard platelets (PLT) concentrate and/or Thrombosomes®) throughout the operation and prior to arrival at the ICU

  6. Total volume of blood product use during surgery

    Time frame: During procedure

    Volume of blood products (RBC, fresh-frozen plasma (FFP), standard platelets (PLT) concentrate and/or Thrombosomes®) throughout the operation and prior to arrival at the ICU

  7. Total number of blood product use during the first 24 hours in the ICU

    Time frame: 24 hours

    Numbers of blood products (RBC, FFP, standard PLT) during the first 24 hours in the ICU

  8. Total units of blood product use during the first 24 hours in the ICU

    Time frame: 24 hours

    Units of blood products (RBC, FFP, standard PLT) during the first 24 hours in the ICU

  9. Number of patients needing re-do surgery due to hemorrhage

    Time frame: 24 hours

    Number of patients with need for re-do surgery due to hemorrhage in the first 24 hours postoperatively

  10. Sequential Organ Failure Assessment (SOFA) score during stay in ICU within 12 days

    Time frame: 12 days

    Sequential Organ Failure Assessment (SOFA) score during stay in ICU within 12 days, or until discharge from ICU, whichever comes first. Scale from 0 to 20 with 20 signifying severe organ failure

  11. Hemostatic product use during surgery

    Time frame: During procedure

    Use of hemostatic products (fibrinogen concentrate, cryoprecipitate, recombinant factor VIIa) during surgery

  12. Vasopressor free days within 30 days

    Time frame: 30 days

    Numbers of vasopressor free days in the ICU within 30 days

  13. Ventilator free days

    Time frame: 30 days

    Numbers of ventilator free days in the ICU within 30 days

  14. Renal replacement free days

    Time frame: 30 days

    Numbers of renal replacement free days in the ICU within 30 days

  15. Length of stay in ICU

    Time frame: 30 days

    Numbers of days in the ICU

  16. Length of stay in hospital

    Time frame: 30 days

    Numbers of days in the hospital

  17. Mortality

    Time frame: 30 days

    30-day mortality after intervention

  18. Symptomatic thrombo-embolic events

    Time frame: 30 days

    Numbers of symptomatic thrombo-embolic events within 30 days after intervention

  19. Serious adverse reactions/events

    Time frame: 12 days

    Number of serious adverse reactions/events within the first 12 days after intervention

Sponsors and collaborators

Lead sponsor

Jakob Stensballe, MD, PhD

Other

Collaborators

  • Cellphire Therapeutics, Inc.

Registry information

Official study 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

Acronym: TTAD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2023
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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