A Phase 2 interventional study of Thrombosomes® and Standard platelet concentrate in Thoracic Aortic Dissection, sponsored by Jakob Stensballe, MD, PhD. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by Jakob Stensballe, MD, PhD · Phase 2, Interventional, and Treatment
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).
30 studies on the registry are indexed under Dissection, Thoracic Aorta; 10 are open to participants now.
This study's enrollment of 41 is below the median of 87 across 13 interventional studies indexed under Dissection, Thoracic Aorta.
Browse Dissection, Thoracic Aorta studies →Jakob Stensballe, MD, PhD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Thrombosomes® (TBX®) up to 3 doses
Biological: Thrombosomes®
Standard platelet concentrate up to 3 doses
Biological: Standard platelet concentrate
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
The administration of standard platelets is administrated, as part of the Massive Transfusion Protocol (MTP).
Also known as: stPC
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
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
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
Time frame: During procedure
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
Time frame: 24 hours
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
Time frame: 24 hours
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
Time frame: 24 hours
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
Time frame: 12 days
Hemostatic product use during surgery
Use of hemostatic products (fibrinogen concentrate, cryoprecipitate, recombinant factor VIIa) during surgery
Time frame: During procedure
Vasopressor free days within 30 days
Numbers of vasopressor free days in the ICU within 30 days
Time frame: 30 days
Ventilator free days
Numbers of ventilator free days in the ICU within 30 days
Time frame: 30 days
Renal replacement free days
Numbers of renal replacement free days in the ICU within 30 days
Time frame: 30 days
Length of stay in ICU
Numbers of days in the ICU
Time frame: 30 days
Length of stay in hospital
Numbers of days in the hospital
Time frame: 30 days
Mortality
30-day mortality after intervention
Time frame: 30 days
Symptomatic thrombo-embolic events
Numbers of symptomatic thrombo-embolic events within 30 days after intervention
Time frame: 30 days
Serious adverse reactions/events
Number of serious adverse reactions/events within the first 12 days after intervention
Time frame: 12 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2023 to primary completion in Apr 2024, 12 months.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Jakob Stensballe, MD, PhD