Thrombosomes® in Acute Thoracic Aortic Dissections

Jakob Stensballe, MD, PhD41 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Thoracic Aortic Dissection

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).

Standard platelet concentrateBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark

Outcomes

Primary Outcomes

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.

Time frame: During procedure

Secondary Outcomes

Bleeding during surgery

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

Time frame: During procedure

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

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

Time frame: Average 3 hours

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

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

Time frame: 24 hours

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

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

Time frame: 24 hours

Total number of blood product use during surgery

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

Time frame: During procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.