Off Pump Coronary Artery Bypass SurgeryTAOPCABNCT01064167
Tranexamic Acid in Off-pump Coronary Surgery
A study testing Tranexamic Acid in people with Off Pump Coronary Artery Bypass Surgery, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass graphing (OPCAB) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Off Pump Coronary Artery Bypass Surgery
- What is being tested?
- Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 1 siteChina
- Study dates
- Feb 2009to Dec 2009
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients for elective offpump coronary artery bypass surgery
Who cannot join
- A history of bleeding disorders
- Active chronic hepatitis or cirrhosis
- Chronic renal insufficiency (serum creatinine > 2 mg/dL)
- Preoperative anemia (Hb < 10 g/dL)
- Previous cardiac surgery
- Myocardial infarction < 7 days before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tranexamic Acid Reduces Blood Loss After Off-pump Coronary Artery Bypass Grafting
The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass graphing (OPCAB) surgery.
Read the detailed description
Cardiac surgical procedures account for a large amount of allogeneic transfusion. Although postoperative bleeding seems to be attenuated by the avoidance of cardiopulmonary bypass (CPB), hemorrhagic complications are not completely eliminated and the consequent need for allogeneic transfusions are still major problems after OPCAB.
Tranexamic acid, a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with CPB. About 30% of patients in OPCAB studies still receive a transfusion. A few small sample size studies concerned with the use of in OPCAB surgery, found that tranexamic acid appear to be effective in reducing postoperative bleeding, however, the results on transfusion requirements are still inconsistency. The purpose of this study was to evaluate the effects of tranexamic acid on the postoperative bleeding and transfusion requirements in a larger number of patients undergoing OPCAB surgery. In addition, the effect of tranexamic acid on mortality, morbidity and resource utilization was examined.
- Conditions
- Off Pump Coronary Artery Bypass Surgery
- Being tested
- Tranexamic Acid
- Keywords
- Tranexamic Acid, off-pump coronary Artery Bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
In tranexamic acid group, tranexamic acid, 1 g, was given 20 minutes before incision and 400 mg/h during the entire surgical procedure. The patients from control group were infused with normal saline as a placebo.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid group | Experimental | Not described Receives: Drug: Tranexamic Acid |
| Control group | Placebo comparator | Not described Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Required Allogenic Red Blood Cells Transfusion
Measured: 1month postoperative
Secondary outcomes (1)
Postoperative Chest Tube Drainage
Measured: 24h postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startFeb 2009
- Primary completionOct 2009
- Study completionDec 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Off Pump Coronary Artery Bypass SurgeryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lihuan Li, M.D, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064167
- Sponsor's protocol ID
- FWMZ013
- Acronym
- TAOPCAB
- Status last verified
- Feb 2010
- First submitted
- 4 Feb 2010
- Last updated
- 3 Feb 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wang G, Xie G, Jiang T, Wang Y, Wang W, Ji H, Liu M, Chen L, Li L. Tranexamic acid reduces blood loss after off-pump coronary surgery: a prospective, randomized, double-blind, placebo-controlled study. Anesth Analg. 2012 Aug;115(2):239-43. doi: 10.1213/ANE.0b013e3182264a11. Epub 2011 Jul 7.
PubMed 21737704
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid Reduces Blood Loss After Off-pump Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT01064167
- Acronym / sponsor ID
- TAOPCAB / FWMZ013
- Conditions
- Off Pump Coronary Artery Bypass Surgery
- Keywords
- Tranexamic Acid, off-pump coronary Artery Bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Feb 2010 (estimated)
- Results
- Posted 3 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass graphing (OPCAB) surgery.
Detailed description
Cardiac surgical procedures account for a large amount of allogeneic transfusion. Although postoperative bleeding seems to be attenuated by the avoidance of cardiopulmonary bypass (CPB), hemorrhagic complications are not completely eliminated and the consequent need for allogeneic transfusions are still major problems after OPCAB.
Tranexamic acid, a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with CPB. About 30% of patients in OPCAB studies still receive a transfusion. A few small sample size studies concerned with the use of in OPCAB surgery, found that tranexamic acid appear to be effective in reducing postoperative bleeding, however, the results on transfusion requirements are still inconsistency. The purpose of this study was to evaluate the effects of tranexamic acid on the postoperative bleeding and transfusion requirements in a larger number of patients undergoing OPCAB surgery. In addition, the effect of tranexamic acid on mortality, morbidity and resource utilization was examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid group | Experimental | Drug: Tranexamic Acid |
| Control group | Placebo comparator | Drug: Tranexamic Acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients for elective offpump coronary artery bypass surgery
Key exclusion criteria (6 listed)
- A history of bleeding disorders
- Active chronic hepatitis or cirrhosis
- Chronic renal insufficiency (serum creatinine > 2 mg/dL)
- Preoperative anemia (Hb < 10 g/dL)
- Previous cardiac surgery
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 AcidIn tranexamic acid group, tranexamic acid, 1 g, was given 20 minutes before incision and 400 mg/h during the entire surgical procedure. The patients from control group were infused with normal saline as a placebo. | Drug | Control group, Tranexamic Acid group |
Primary outcome
Number of Patients Required Allogenic Red Blood Cells Transfusion
Time frame: 1month postoperative
1 secondary outcome
Postoperative Chest Tube Drainage
Time frame: 24h postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21737704Wang G, Xie G, Jiang T, Wang Y, Wang W, Ji H, Liu M, Chen L, Li L. Tranexamic acid reduces blood loss after off-pump coronary surgery: a prospective, randomized, double-blind, placebo-controlled study. Anesth Analg. 2012 Aug;115(2):239-43. doi: 10.1213/ANE.0b013e3182264a11. Epub 2011 Jul 7.
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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.
Lihuan Li, M.D study chair
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid in people with Off Pump Coronary Artery Bypass Surgery, 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 6 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 3 Feb 2011. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2011). 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?
Number of Patients Required Allogenic Red Blood Cells Transfusion (time frame: 1month postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01064167, which also lists 1 linked publication.
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 3 Feb 2011; AzTrials last refreshed its copy on 26 Oct 2026.