Thrombosomes® in Acute Thoracic Aortic Dissections

Thoracic Aortic Dissection Clinical Trial

— TTAD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05771831
• Other study ID #: H-22061913
• Status: Completed
• Phase: Phase 2
• Start date: March 15, 2023
• Est. completion date: April 11, 2024

Study information

• Verified date: May 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 11, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Aortic Dissection
• Thoracic Aortic Dissection

Intervention

Biological:
• Thrombosomes®
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 concentrate
The administration of standard platelets is administrated, as part of the Massive Transfusion Protocol (MTP).

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Copenhagen University Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Jakob Stensballe, MD, PhD	Cellphire Therapeutics, Inc.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	During procedure
Secondary	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)	Average 3 hours
Secondary	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	24 hours
Secondary	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	24 hours
Secondary	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	During procedure
Secondary	Total volume of blood product use during surgery	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	During procedure
Secondary	Total number of blood product use during the first 24 hours in the ICU	Numbers of blood products (RBC, FFP, standard PLT) during the first 24 hours in the ICU	24 hours
Secondary	Total units of blood product use during the first 24 hours in the ICU	Units of blood products (RBC, FFP, standard PLT) during the first 24 hours in the ICU	24 hours
Secondary	Number of patients needing re-do surgery due to hemorrhage	Number of patients with need for re-do surgery due to hemorrhage in the first 24 hours postoperatively	24 hours
Secondary	Sequential Organ Failure Assessment (SOFA) score during stay in ICU within 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	12 days
Secondary	Hemostatic product use during surgery	Use of hemostatic products (fibrinogen concentrate, cryoprecipitate, recombinant factor VIIa) during surgery	During procedure
Secondary	Vasopressor free days within 30 days	Numbers of vasopressor free days in the ICU within 30 days	30 days
Secondary	Ventilator free days	Numbers of ventilator free days in the ICU within 30 days	30 days
Secondary	Renal replacement free days	Numbers of renal replacement free days in the ICU within 30 days	30 days
Secondary	Length of stay in ICU	Numbers of days in the ICU	30 days
Secondary	Length of stay in hospital	Numbers of days in the hospital	30 days
Secondary	Mortality	30-day mortality after intervention	30 days
Secondary	Symptomatic thrombo-embolic events	Numbers of symptomatic thrombo-embolic events within 30 days after intervention	30 days
Secondary	Serious adverse reactions/events	Number of serious adverse reactions/events within the first 12 days after intervention	12 days