Cardiac Surgical ProceduresPhase 4NCT04911413
Comparison of Three Tranexamic Acid Dose Regimens in Patients Undergoing Cardiac Valve Surgery
A Phase 4 study testing Tranexamic acid in people with Cardiac Surgical Procedures and Blood Transfusion, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
This study compares the effect of three different dose levels of tranexamic acid（TXA）in reducing blood loss and transfusion requirements in cardiac valve surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cardiac Surgical Procedures, Blood Transfusion, Tranexamic Acid
- What is being tested?
- Tranexamic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 15 Jun 2021
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients aged between 18 to 60 years old scheduled for cardiac valve surgery (replacement or plasty) requiring CPB
Who cannot join
- known allergy to TXA, combined CABG operation or other cardiac procedures other than valve surgery, previous cardiac surgery, EF<45% or cardiothoracic ratio>0.65, serious coagulation disorder, serious hepatic insufficiency, receiving antiplatelet therapy at any time within 7 days of surgery, receiving low molecular weight heparin at any time within 24 hours of surgery, and pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
About this study
This study compares the effect of three different dose levels of tranexamic acid（TXA）in reducing blood loss and transfusion requirements in cardiac valve surgery.
Read the detailed description
The effect of TXA to reduce perioperative blood loss and blood transfusion has been well established in many trials, but the optimal dosage of TXA in cardiac surgery has always been a problem of debate. This is a single-center randomized controlled trial to study different dose regimens of TXA in cardiac surgery. We use three different dose levels of TXA in cardiac valve surgery with CPB, and see if there are any differences in perioperative blood loss and transfusion requirements. Serious adverse events and seizure attacks are also recorded until three months after surgery.
- Being tested
- Tranexamic acid
- Keywords
- Cardiac Surgery, Blood transfusion, Blood loss, Tranexamic Acid, Dose regimen
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Cyklokapron, Transamin
The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.
| Study group | Role | What they receive |
|---|---|---|
| low-dose group, | Experimental | A bolus of 10 mg/kg Tranexamic Acid followed by a maintenance dose of 10 mg/kg/h Tranexamic Acid until the end of surgery Receives: Drug: Tranexamic acid |
| middle-dose group, | Experimental | A bolus of 20 mg/kg Tranexamic Acid followed by a maintenance dose of 15 mg/kg/h Tranexamic Acid until the end of surgery Receives: Drug: Tranexamic acid |
| high-dose group | Experimental | A bolus of 30 mg/kg Tranexamic Acid followed by a maintenance dose of 20 mg/kg/h Tranexamic Acid until the end of surgery Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
total postoperative drainage
The total chest tube drainage postoperatively
Measured: from the operation day to the discharge，an average of 7 days
Secondary outcomes (7)
Red blood cells transfusion rate（%），Red blood cells transfusion volume（ml）
intraoperative and postoperative RBC transfusion rate and transfusion volume（for all patients and for transfused patients）
Measured: from the operation day to the discharge，an average of 7 days
Fresh frozen plasma transfusion rate（%），Fresh frozen plasma transfusion volume（ml）
intraoperative and postoperative FFP transfusion rate and transfusion volume（for all patients and for transfused patients）
Measured: from the operation day to the discharge，an average of 7 days
Platelet transfusion rate（%），Platelet transfusion volume（ml）
intraoperative and postoperative platelet transfusion rate and transfusion volume（for all patients and for transfused patients）
Measured: from the operation day to the discharge，an average of 7 days
repeat surgery because of bleeding
rate of repeat surgery due to massive bleeding
Measured: from the operation day to the discharge，an average of 7 days
rate of death
rate of death
Measured: from the operation day to three months after surgery
seizure attack
any seizure attack is recorded
Measured: from the operation day to three months after surgery
length of stay in ICU and hospital
the length of stay in ICU and hospital
Measured: from the operation day to the discharge，an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Sep 2017
- Primary completion5 Mar 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911413
- Sponsor's protocol ID
- TXA dosage trial 2
- Status last verified
- Aug 2021
- First submitted
- 25 May 2021
- Last updated
- 31 Aug 2021
- Results posted
- 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 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Tranexamic Acid Dose Regimens in Patients Undergoing Cardiac Valve Surgery
- ClinicalTrials.gov ID
- NCT04911413
- Acronym / sponsor ID
- TXA dosage trial 2
- Keywords
- Cardiac Surgery, Blood transfusion, Blood loss, Tranexamic Acid, Dose regimen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 3 Jun 2021 (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.
This study compares the effect of three different dose levels of tranexamic acid（TXA）in reducing blood loss and transfusion requirements in cardiac valve surgery.
Detailed description
The effect of TXA to reduce perioperative blood loss and blood transfusion has been well established in many trials, but the optimal dosage of TXA in cardiac surgery has always been a problem of debate. This is a single-center randomized controlled trial to study different dose regimens of TXA in cardiac surgery. We use three different dose levels of TXA in cardiac valve surgery with CPB, and see if there are any differences in perioperative blood loss and transfusion requirements. Serious adverse events and seizure attacks are also recorded until three months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low-dose group, | Experimental | Drug: Tranexamic acidA bolus of 10 mg/kg Tranexamic Acid followed by a maintenance dose of 10 mg/kg/h Tranexamic Acid until the end of surgery |
| middle-dose group, | Experimental | Drug: Tranexamic acidA bolus of 20 mg/kg Tranexamic Acid followed by a maintenance dose of 15 mg/kg/h Tranexamic Acid until the end of surgery |
| high-dose group | Experimental | Drug: Tranexamic acidA bolus of 30 mg/kg Tranexamic Acid followed by a maintenance dose of 20 mg/kg/h Tranexamic Acid until the end of surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients aged between 18 to 60 years old scheduled for cardiac valve surgery (replacement or plasty) requiring CPB
Key exclusion criteria (1 listed)
- known allergy to TXA, combined CABG operation or other cardiac procedures other than valve surgery, previous cardiac surgery, EF<45% or cardiothoracic ratio>0.65, serious coagulation disorder, serious hepatic insufficiency, receiving antiplatelet therapy at any time within 7 days of surgery, receiving low molecular weight heparin at any time within 24 hours of surgery, and pregnancy.
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 acidAlso: Cyklokapron, TransaminThe drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups. | Drug | high-dose group, low-dose group,, middle-dose group, |
Primary outcome
total postoperative drainage
Time frame: from the operation day to the discharge，an average of 7 days
The total chest tube drainage postoperatively
7 secondary outcomes
Red blood cells transfusion rate（%），Red blood cells transfusion volume（ml）
Time frame: from the operation day to the discharge，an average of 7 days
Fresh frozen plasma transfusion rate（%），Fresh frozen plasma transfusion volume（ml）
Time frame: from the operation day to the discharge，an average of 7 days
Platelet transfusion rate（%），Platelet transfusion volume（ml）
Time frame: from the operation day to the discharge，an average of 7 days
repeat surgery because of bleeding
Time frame: from the operation day to the discharge，an average of 7 days
rate of death
Time frame: from the operation day to three months after surgery
seizure attack
Time frame: from the operation day to three months after surgery
length of stay in ICU and hospital
Time frame: from the operation day to the discharge，an average of 7 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 31 Aug 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Cardiac Surgical Procedures and Blood Transfusion, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
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 1 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 31 Aug 2021. 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 China. 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 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?
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?
total postoperative drainage (time frame: from the operation day to the discharge，an average of 7 days). 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 31 Aug 2021.