Surgery, CardiacPhase 4NCT06109155
The Effect of ACT and Tranexamic Acid on Bleeding in Cardiac Surgery
A Phase 4 study testing Tranexamic acid in people with Surgery, Cardiac and Tranxemic Acid, run by Taichung Veterans General Hospital at 2 sites in Taiwan.
Trial summary
The goal of this clinical trial is to the dose effect of tranexamic acid and the level of ACT on bleeding in adult cardiac surgery. The main questions it aims to answer are: 1. Does higher dose of tranexamic acid reduce the amount of bleeding and blood transfusion? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Cardiac, Tranxemic Acid, Activated Clotting Time
- What is being tested?
- Tranexamic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesTaiwan
- Study dates
- 8 Feb 2024to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- adult, cardiac surgery with cardiopulmonary bypass
Who cannot join
- pregnant
- emergency procedure
- immune compromised
- aortic surgery
- end-stage renal disease
- liver disease
- critical status
- incomplete clinical data
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Yung-Szu Wu
- Recruiting
Taichung Veterans General hospital
Taichung, 40705
Yung Szu Wu
About this study
Official title: The Dose Effect of Activated Clotting Time and Tranexamic Acid on Bleeding in Adult Cardiac Surgery
The goal of this clinical trial is to the dose effect of tranexamic acid and the level of ACT on bleeding in adult cardiac surgery.
The main questions it aims to answer are:
- Does higher dose of tranexamic acid reduce the amount of bleeding and blood transfusion?
- Does lower ACT level during cardiac surgery reduce the amount of bleeding and blood transfusion?
Participants will divided into four groups which have different tranexamic acid dose and ACT level during cardiac surgery to see if there is any different in the amount of bleeding and blood transfusion.
Read the detailed description
This study is going to analyze the medical records of patients who underwent cardiac surgery between December 1, 2023, and December 31, 2026.
The investigators will categorize patients into four groups based on anticoagulation indices (ACT 400-600 seconds; ACT > 600 seconds) and tranexamic acid dosages (low dose; high dose) within the range considered safe for CPB.
The primary outcome will be the volume of postoperative bleeding within 24 hours for each group.
The findings of this study will contribute to the existing clinical evidence and provide insights for the monitoring and pharmacological management in cardiac surgery.
- Conditions
- Surgery, Cardiac, Tranxemic Acid, Activated Clotting Time, Heparin, Cardiopulmonary Bypass
- Being tested
- Tranexamic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
tranexamic acid will be used in two different doses (50mg/kg vs 20mg/kg). the tranexamic acid pump will start from the begin of anesthesia until all dose is administrated.
| Study group | Role | What they receive |
|---|---|---|
| High dose tranexamic acid + high ACT level | Active comparator | high dose tranexamic acid: 50mg/kg ACT level: > 600 sec Receives: Drug: Tranexamic acid |
| High dose tranexamic acid + low ACT level | Active comparator | high dose tranexamic acid: 50mg/kg ACT level: 400~ 600 sec Receives: Drug: Tranexamic acid |
| Low dose tranexamic acid + low ACT level | Active comparator | Low dose tranxeamic acid: 20mg/kg ACT level: 400~ 600 sec Receives: Drug: Tranexamic acid |
| Low dose tranexamic acid + high ACT level | Placebo comparator | Low dose tranxeamic acid: 20mg/kg ACT level: > 600 sec Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
monitor the amount of blood loss after procedure
Measured: 24 hours
blood transfusion
the amount of blood transfusion during procedure
Measured: procedure time, an average of 6 hours
Secondary outcomes (1)
30-day mortality
30-day mortality after procedure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start8 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery, CardiacStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- During cardiac surgery with cardiopulmonary bypass support, participants will be divided into 4 groups. During procedure, they will recieve different doses of tranexamic acid and different level of activated clotting time. Then, we will monitor the amount of blood loss and blood transfusion.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109155
- Sponsor's protocol ID
- CF23323A
- Status last verified
- Feb 2024
- First submitted
- 22 Sep 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dose Effect of Activated Clotting Time and Tranexamic Acid on Bleeding in Adult Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06109155
- Acronym / sponsor ID
- CF23323A
- Conditions
- Surgery, Cardiac, Tranxemic Acid, Activated Clotting Time, Heparin, Cardiopulmonary Bypass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Oct 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 goal of this clinical trial is to the dose effect of tranexamic acid and the level of ACT on bleeding in adult cardiac surgery.
The main questions it aims to answer are:
- Does higher dose of tranexamic acid reduce the amount of bleeding and blood transfusion?
- Does lower ACT level during cardiac surgery reduce the amount of bleeding and blood transfusion?
Participants will divided into four groups which have different tranexamic acid dose and ACT level during cardiac surgery to see if there is any different in the amount of bleeding and blood transfusion.
Detailed description
This study is going to analyze the medical records of patients who underwent cardiac surgery between December 1, 2023, and December 31, 2026.
The investigators will categorize patients into four groups based on anticoagulation indices (ACT 400-600 seconds; ACT > 600 seconds) and tranexamic acid dosages (low dose; high dose) within the range considered safe for CPB.
The primary outcome will be the volume of postoperative bleeding within 24 hours for each group.
The findings of this study will contribute to the existing clinical evidence and provide insights for the monitoring and pharmacological management in cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- During cardiac surgery with cardiopulmonary bypass support, participants will be divided into 4 groups. During procedure, they will recieve different doses of tranexamic acid and different level of activated clotting time. Then, we will monitor the amount of blood loss and blood transfusion.
| Arm | Type | Receives |
|---|---|---|
| High dose tranexamic acid + high ACT level | Active comparator | Drug: Tranexamic acidhigh dose tranexamic acid: 50mg/kg ACT level: > 600 sec |
| High dose tranexamic acid + low ACT level | Active comparator | Drug: Tranexamic acidhigh dose tranexamic acid: 50mg/kg ACT level: 400~ 600 sec |
| Low dose tranexamic acid + low ACT level | Active comparator | Drug: Tranexamic acidLow dose tranxeamic acid: 20mg/kg ACT level: 400~ 600 sec |
| Low dose tranexamic acid + high ACT level | Placebo comparator | Drug: Tranexamic acidLow dose tranxeamic acid: 20mg/kg ACT level: > 600 sec |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult, cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (8 listed)
- pregnant
- emergency procedure
- immune compromised
- aortic surgery
- end-stage renal disease
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 |
|---|---|---|
| Tranexamic acidtranexamic acid will be used in two different doses (50mg/kg vs 20mg/kg). the tranexamic acid pump will start from the begin of anesthesia until all dose is administrated. | Drug | High dose tranexamic acid + high ACT level, High dose tranexamic acid + low ACT level, Low dose tranexamic acid + high ACT level, Low dose tranexamic acid + low ACT level |
Primary outcome
Blood loss
Time frame: 24 hours
monitor the amount of blood loss after procedure
blood transfusion
Time frame: procedure time, an average of 6 hours
the amount of blood transfusion during procedure
1 secondary outcome
30-day mortality
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid in people with Surgery, Cardiac and Tranxemic Acid, run by Taichung Veterans General Hospital at 2 sites in Taiwan.
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 1 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yung-Szu Wu, MD (0423592525 ext. 5063, adconvert98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 21 Feb 2024.