Thoracic Aortic DissectionPhase 2TTADNCT05771831
Thrombosomes® in Acute Thoracic Aortic Dissections
A Phase 2 study testing Thrombosomes® and Standard platelet concentrate in people with Thoracic Aortic Dissection, run by Jakob Stensballe, MD, PhD at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Dissection
- What is being tested?
- Thrombosomes® and Standard platelet concentrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2023to 11 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient eligible for emergency surgery on cardiopulmonary bypass pump for acute thoracic aortic dissections
- Age ≥ 18 years
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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).
- Conditions
- Thoracic Aortic Dissection
- Being tested
- Thrombosomes®, Standard platelet concentrate
- Keywords
- Surgery, Bleeding
- Medical subject headings
- Dissection, Thoracic Aorta, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombosomes®Biological
Also called TBX®, Freeze-dried platelets
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
Also called stPC
The administration of standard platelets is administrated, as part of the Massive Transfusion Protocol (MTP).
| Study group | Role | What they receive |
|---|---|---|
| Thrombosomes® | Experimental | Thrombosomes® (TBX®) up to 3 doses Receives: Biological: Thrombosomes® |
| Standard platelet concentrate | Active comparator | Standard platelet concentrate up to 3 doses Receives: Biological: Standard platelet concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During procedure
Secondary outcomes (19)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 days
Hemostatic product use during surgery
Use of hemostatic products (fibrinogen concentrate, cryoprecipitate, recombinant factor VIIa) during surgery
Measured: During procedure
Vasopressor free days within 30 days
Numbers of vasopressor free days in the ICU within 30 days
Measured: 30 days
Ventilator free days
Numbers of ventilator free days in the ICU within 30 days
Measured: 30 days
Renal replacement free days
Numbers of renal replacement free days in the ICU within 30 days
Measured: 30 days
Length of stay in ICU
Numbers of days in the ICU
Measured: 30 days
Length of stay in hospital
Numbers of days in the hospital
Measured: 30 days
Mortality
30-day mortality after intervention
Measured: 30 days
Symptomatic thrombo-embolic events
Numbers of symptomatic thrombo-embolic events within 30 days after intervention
Measured: 30 days
Serious adverse reactions/events
Number of serious adverse reactions/events within the first 12 days after intervention
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start15 Mar 2023
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel groups, patients entering in either intervention arm or standard treatment
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jakob Stensballe, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Cellphire Therapeutics, Inc.
- Responsible party
- Sponsor-investigator, Jakob Stensballe, MD, PhD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Annette Ulrich, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771831
- Sponsor's protocol ID
- H-22061913
- Acronym
- TTAD
- Status last verified
- May 2024
- First submitted
- 15 Feb 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05771831
- Acronym / sponsor ID
- TTAD / H-22061913
- Conditions
- Thoracic Aortic Dissection
- Keywords
- Surgery, Bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Jakob Stensballe, MD, PhDUniversity, hospital or other
- Collaborators
- Cellphire Therapeutics, Inc.
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel groups, patients entering in either intervention arm or standard treatment
| Arm | Type | Receives |
|---|---|---|
| Thrombosomes® | Experimental | Biological: Thrombosomes®Thrombosomes® (TBX®) up to 3 doses |
| Standard platelet concentrate | Active comparator | Biological: Standard platelet concentrateStandard platelet concentrate up to 3 doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient eligible for emergency surgery on cardiopulmonary bypass pump for acute thoracic aortic dissections
- Age ≥ 18 years
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrombosomes®Also: TBX®, Freeze-dried plateletsThe intervention with TBX® is to be administered as an intravenous infusion as hemostatic blood product as part of the Massive Transfusion Protocol (MTP). | Biological | Thrombosomes® |
| Standard platelet concentrateAlso: stPCThe administration of standard platelets is administrated, as part of the Massive Transfusion Protocol (MTP). | Biological | Standard platelet concentrate |
Primary outcome
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.
19 secondary outcomes
Bleeding during surgery
Time frame: During procedure
Bleeding in chest tubes and mediastinal drainages on arrival in the ICU
Time frame: Average 3 hours
Bleeding in mL in chest tube and mediastinal drainage at 24 hour after arrival in the ICU
Time frame: 24 hours
Bleeding in mL/kg in chest tube and mediastinal drainage at 24 hour after arrival in the ICU
Time frame: 24 hours
Total number of blood product use during surgery
Time frame: During procedure
Total volume of blood product use during surgery
Time frame: During procedure
Total number of blood product use 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
Time frame: 24 hours
Number of patients needing re-do surgery due to hemorrhage
Time frame: 24 hours
Sequential Organ Failure Assessment (SOFA) score during stay in ICU within 12 days
Time frame: 12 days
Hemostatic product use during surgery
Time frame: During procedure
Vasopressor free days within 30 days
Time frame: 30 days
Ventilator free days
Time frame: 30 days
Renal replacement free days
Time frame: 30 days
Length of stay in ICU
Time frame: 30 days
Length of stay in hospital
Time frame: 30 days
Mortality
Time frame: 30 days
Symptomatic thrombo-embolic events
Time frame: 30 days
Serious adverse reactions/events
Time frame: 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Ulrich, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thrombosomes® and Standard platelet concentrate in people with Thoracic Aortic Dissection, run by Jakob Stensballe, MD, PhD at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to hemostasis during surgery (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.