C.Surgical Procedure; CardiacPhase 4NCT01998438
Prospective Trial of Tranexamic Acid in Cardiac Surgery
A Phase 4 study testing Tranexamic Acid in people with C.Surgical Procedure; Cardiac, run by Hongwen Ji at 1 site in China.
Trial summary
Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is still unknown. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- C.Surgical Procedure; Cardiac
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 955 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Sep 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Noncyanotic congenital heart disease patients requiring cardiac surgeries under cardiopulmonary bypass
- Rheumatic or recessive valvular disease patients requiring valvular repair or replacement under cardiopulmonary bypass
- Coronary artery disease patients requiring coronary artery bypass graft under cardiopulmonary bypass
Who cannot join
- Non-primary and emergency cardiac surgery
- Disorder in coagulation function before surgery
- Anemia before surgery
- Definite liver and renal dysfunction
- History of stroke
- Pregnancy and lactation
- Disabled in spirit or law
- Fatal conditions such as cancer
Trial locations and contacts
1 site in 1 country.
China1 site
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, 100037
About this study
Official title: A Randomized Double-blinded Trial to Explore the Optimum Dose of Tranexamic Acid in Cardiopulmonary Bypass Cardiac Surgery
Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is still unknown. We use three different doses to find which is the optimum dose of tranexamic acid in cardiopulmonary bypass cardiac surgery.
- Conditions
- C.Surgical Procedure; Cardiac
- Being tested
- Tranexamic Acid
- Keywords
- tranexamic acid, cardiac surgery, cardiopulmonary bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called SINE, Tranexamic Acid Injection, 120902
The loading doses were given in 15 minutes when incision.
| Study group | Role | What they receive |
|---|---|---|
| small dose | Experimental | 10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery Receives: Drug: Tranexamic Acid |
| medium dose | Experimental | 20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery Receives: Drug: Tranexamic Acid |
| large dose | Experimental | 30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion 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.
Postoperative Blood Loss
Measured: 24hrs postoperatively
Secondary outcomes (1)
Number of Participants Needs Allogenic Transfusion
Measured: on the 7th day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for C.Surgical Procedure; CardiacStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 955 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hongwen Ji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongwen Ji, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Hongwen Ji, MD, Study chair, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMCHaisong Lu, Principal investigator, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998438
- Sponsor's protocol ID
- 2011GWH1
- Status last verified
- Jan 2016
- First submitted
- 12 Nov 2013
- Last updated
- 26 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blinded Trial to Explore the Optimum Dose of Tranexamic Acid in Cardiopulmonary Bypass Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01998438
- Acronym / sponsor ID
- 2011GWH1
- Conditions
- C.Surgical Procedure; Cardiac
- Keywords
- tranexamic acid, cardiac surgery, cardiopulmonary bypass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 955 participants (actual)
- Lead sponsor
- Hongwen JiUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Posted 26 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is still unknown. We use three different doses to find which is the optimum dose of tranexamic acid in cardiopulmonary bypass cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| small dose | Experimental | Drug: Tranexamic Acid10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery |
| medium dose | Experimental | Drug: Tranexamic Acid20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery |
| large dose | Experimental | Drug: Tranexamic Acid30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Noncyanotic congenital heart disease patients requiring cardiac surgeries under cardiopulmonary bypass
- Rheumatic or recessive valvular disease patients requiring valvular repair or replacement under cardiopulmonary bypass
- Coronary artery disease patients requiring coronary artery bypass graft under cardiopulmonary bypass
Key exclusion criteria (8 listed)
- Non-primary and emergency cardiac surgery
- Disorder in coagulation function before surgery
- Anemia before surgery
- Definite liver and renal dysfunction
- History of stroke
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: SINE, Tranexamic Acid Injection, 120902The loading doses were given in 15 minutes when incision. | Drug | large dose, medium dose, small dose |
Primary outcome
Postoperative Blood Loss
Time frame: 24hrs postoperatively
1 secondary outcome
Number of Participants Needs Allogenic Transfusion
Time frame: on the 7th day postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for C.Surgical Procedure; Cardiac
Active, not recruiting
Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
C.Surgical Procedure; Cardiac
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.
Hongwen Ji, MD study chair
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Haisong Lu principal investigator
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
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 C.Surgical Procedure; Cardiac, run by Hongwen Ji 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 3 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: finished, as of the sponsor's last update on 26 Feb 2016. 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?
Yes. Results are posted in the registry (first posted 26 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Blood Loss (time frame: 24hrs postoperatively). 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 26 Feb 2016; AzTrials last refreshed its copy on 7 Nov 2026.