Thoracic Aortic Dissection
Conditions
Keywords
Surgery, Bleeding
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).
Detailed 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).
Interventions
BIOLOGICALThrombosomes®
The intervention with TBX® is to be administered as an intravenous infusion as hemostatic blood product as part of the Massive Transfusion Protocol (MTP).
BIOLOGICALStandard platelet concentrate
The administration of standard platelets is administrated, as part of the Massive Transfusion Protocol (MTP).
Sponsors
Cellphire Therapeutics, Inc.
Jakob Stensballe, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label treatment. Only statistician performing the data analysis will be blinded
Intervention model description
Parallel groups, patients entering in either intervention arm or standard treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to hemostasis during surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Bleeding in chest tubes and mediastinal drainages on arrival in the ICU | Average 3 hours | Volume of bleeding in chest tubes and mediastinal drains from end of surgery to arrival in the Intensive Care Unit (ICU) |
| Bleeding in mL in chest tube and mediastinal drainage at 24 hour after arrival in the ICU | 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 |
| Bleeding in mL/kg in chest tube and mediastinal drainage at 24 hour after arrival in the ICU | 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 |
| Total number of blood product use during surgery | 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 |
| Total volume of blood product use during surgery | 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 |
| Total number of blood product use during the first 24 hours in the ICU | 24 hours | Numbers of blood products (RBC, FFP, standard PLT) during the first 24 hours in the ICU |
| Total units of blood product use during the first 24 hours in the ICU | 24 hours | Units of blood products (RBC, FFP, standard PLT) during the first 24 hours in the ICU |
| Number of patients needing re-do surgery due to hemorrhage | 24 hours | Number of patients with need for re-do surgery due to hemorrhage in the first 24 hours postoperatively |
| Sequential Organ Failure Assessment (SOFA) score during stay in ICU within 12 days | 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 |
| Bleeding during surgery | During procedure | Bleeding during surgery as measured by suction, cell salvage, chest tubes, mediastinal drains, extracorporeal circulation (ECC), and in the field of surgery |
| Vasopressor free days within 30 days | 30 days | Numbers of vasopressor free days in the ICU within 30 days |
| Ventilator free days | 30 days | Numbers of ventilator free days in the ICU within 30 days |
| Renal replacement free days | 30 days | Numbers of renal replacement free days in the ICU within 30 days |
| Length of stay in ICU | 30 days | Numbers of days in the ICU |
| Length of stay in hospital | 30 days | Numbers of days in the hospital |
| Mortality | 30 days | 30-day mortality after intervention |
| Symptomatic thrombo-embolic events | 30 days | Numbers of symptomatic thrombo-embolic events within 30 days after intervention |
| Serious adverse reactions/events | 12 days | Number of serious adverse reactions/events within the first 12 days after intervention |
| Hemostatic product use during surgery | During procedure | Use of hemostatic products (fibrinogen concentrate, cryoprecipitate, recombinant factor VIIa) during surgery |
Countries
Denmark
Outcome results
None listed