Coronary Artery DiseaseTRACEDNCT01060163
Tranexamic Acid in Clopidogrel Exposure to Decrease Hemorrhage and Transfusion
A study testing Tranexamic Acid and Saline in people with Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 7 sites in China.
Trial summary
The use of platelet aggregation inhibitors, including aspirin and clopidogrel(CPDG), has become a standard management strategy for patients with acute coronary syndrome. On this background, an increasing percentage of patients presenting for surgical coronary revascularization is the subject to irreversible platelet… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Tranexamic Acid and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 552 participants
- Where
- 7 sitesChina
- Study dates
- Jan 2010to Oct 2011
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring primary and isolated coronary artery bypass grafting with cardiopulmonary bypass
Who cannot join
- history of cardiac surgery
- hematocrit <33%
- platelet count <100,000/ml
- allergy to tranexamic acid
- recruited in other studies
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Capital Medical University affiliated Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Cardiovascular Institute and Fuwai Hospital, CMAS&PUMC
Beijing, Beijing Municipality, 100037
General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, 100853
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
Shanghai Jiaotong University affiliated Chest Hospital
Shanghai, Shanghai Municipality, 200030
TEDA International Cardiovascular Hospital
Tianjin, Tianjin Municipality, 300457
the Fourth Military Medical University affiliated Xijing Hospital
Xi’an, Shanxi, 710032
About this study
Official title: Effects of Antifibrinolytics on Bleeding and Transfusion Outcomes in Patients Receiving Coronary Artery Bypass Surgery With Preoperative Clopidogrel Exposure
The use of platelet aggregation inhibitors, including aspirin and clopidogrel(CPDG), has become a standard management strategy for patients with acute coronary syndrome. On this background, an increasing percentage of patients presenting for surgical coronary revascularization is the subject to irreversible platelet inhibition.
Investigations on the effect of antiplatelet treatment on postoperative bleeding after cardiac surgery have shown that patients treated with antiplatelet agents until surgery have increased postoperative bleeding, and also an increased need for transfusions of blood products. As a result of the antiplatelet effect of clopidogrel, the frequency of serious bleeding complications has increased significantly, as seen in patients requiring coronary artery bypass grafting(CABG), especially when they received clopidogrel until surgery.
Read more
Tranexamic acid(TA) is a widely used antifibrinolytic agent, and is a promising substitute for aprotinin when the latter has seceded in 2007.The release of plasmin during cardiopulmonary bypass(CPB) activates fibrinolysis and may contribute to platelet dysfunction. Pharmacological inhibition of the fibrinolytic system may therefore ameliorate platelet dysfunction and fibrinolysis after CPB and decrease postoperative bleeding. Tranexamic acid prevents plasmin formation and inhibits fibrinolysis.
Concerning the cessation of aprotinin and the increasing proportion of patients with persistence on clopidogrel until their surgery, evolutional work is expected, especially in the eastern population.
The purpose of this study is to assess the effect of tranexamic acid in patients with clopidogrel and asprin ingestion until surgery. The investigators working hypothesis was that tranexamic acid would lower postoperative blood loss and transfusion requirements in these patients and would attenuate bleeding complication of antiplatelet therapy.
- Conditions
- Coronary Artery Disease
- Being tested
- Tranexamic Acid, Saline
- Keywords
- Clopidogrel, Tranexamic Acid, Cardiac Surgical Procedures, Hemostasis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
A bolus of 10 mg/kg after anesthetic induction over 10 min followed by a maintenance of 10 mg/kg/h for the duration of surgery
SalineDrug
Saline served as placebo
| Study group | Role | What they receive |
|---|---|---|
| group ET | Experimental | Patients receiving early CABG <=7 days of the cessation of clopidogrel, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery. Receives: Drug: Tranexamic Acid |
| group EP | Placebo comparator | Patients receiving early CABG <= 7 days of the cessation of clopidogrel, treated with placebo(saline solution) Receives: Drug: Saline |
| group LT | Experimental | Patients receiving late CABG >7 days of the cessation of clopidogrel, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery. Receives: Drug: Tranexamic Acid |
| group LP | Placebo comparator | Patients receiving late CABG >7 days of the cessation of clopidogrel, treated with placebo(saline solution) Receives: Drug: Saline |
| group BT | Experimental | Patients receiving CABG without preoperative clopidogrel exposure, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery. Receives: Drug: Tranexamic Acid |
| group BP | Placebo comparator | Patients receiving CABG without preoperative clopidogrel exposure, treated with placebo(saline solution) Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative blood loss(chest drainage)
Measured: on the 120th day postoperatively
Incidence of major bleeding
Measured: on the 120th day postoperatively
RBC Transfusion (volume and rate)
Measured: on the 120th day postoperatively
Secondary outcomes (2)
Mortality
Measured: on the 120th day postoperatively
Major morbidity
The major morbidity end points were defined as permanent disability caused by stroke, postoperative myocardial infarction, renal failure and respiratory failure.
Measured: on the 120th day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Lihuan, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Lihuang Li, MD, Study chair, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMCJia Shi, MD, Principal investigator, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060163
- Sponsor's protocol ID
- the TRACED trial
- Acronym
- TRACED
- Status last verified
- Nov 2011
- First submitted
- 28 Jan 2010
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shi J, Ji H, Ren F, Wang G, Xu M, Xue Y, Chen M, Qi J, Li L. Protective effects of tranexamic acid on clopidogrel before coronary artery bypass grafting: a multicenter randomized trial. JAMA Surg. 2013 Jun;148(6):538-47. doi: 10.1001/jamasurg.2013.1560.
PubMed 23426385
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antifibrinolytics on Bleeding and Transfusion Outcomes in Patients Receiving Coronary Artery Bypass Surgery With Preoperative Clopidogrel Exposure
- ClinicalTrials.gov ID
- NCT01060163
- Acronym / sponsor ID
- TRACED / the TRACED trial
- Conditions
- Coronary Artery Disease
- Keywords
- Clopidogrel, Tranexamic Acid, Cardiac Surgical Procedures, Hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Feb 2010 (estimated)
- 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 use of platelet aggregation inhibitors, including aspirin and clopidogrel(CPDG), has become a standard management strategy for patients with acute coronary syndrome. On this background, an increasing percentage of patients presenting for surgical coronary revascularization is the subject to irreversible platelet inhibition.
Investigations on the effect of antiplatelet treatment on postoperative bleeding after cardiac surgery have shown that patients treated with antiplatelet agents until surgery have increased postoperative bleeding, and also an increased need for transfusions of blood products. As a result of the antiplatelet effect of clopidogrel, the frequency of serious bleeding complications has increased significantly, as seen in patients requiring coronary artery bypass grafting(CABG), especially when they received clopidogrel until surgery.
Tranexamic acid(TA) is a widely used antifibrinolytic agent, and is a promising substitute for aprotinin when the latter has seceded in 2007.The release of plasmin during cardiopulmonary bypass(CPB) activates fibrinolysis and may contribute to platelet dysfunction. Pharmacological inhibition of the fibrinolytic system may therefore ameliorate platelet dysfunction and fibrinolysis after CPB and decrease postoperative bleeding. Tranexamic acid prevents plasmin formation and inhibits fibrinolysis.
Concerning the cessation of aprotinin and the increasing proportion of patients with persistence on clopidogrel until their surgery, evolutional work is expected, especially in the eastern population.
The purpose of this study is to assess the effect of tranexamic acid in patients with clopidogrel and asprin ingestion until surgery. The investigators working hypothesis was that tranexamic acid would lower postoperative blood loss and transfusion requirements in these patients and would attenuate bleeding complication of antiplatelet therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| group ET | Experimental | Drug: Tranexamic AcidPatients receiving early CABG <=7 days of the cessation of clopidogrel, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery. |
| group EP | Placebo comparator | Drug: SalinePatients receiving early CABG <= 7 days of the cessation of clopidogrel, treated with placebo(saline solution) |
| group LT | Experimental | Drug: Tranexamic AcidPatients receiving late CABG >7 days of the cessation of clopidogrel, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery. |
| group LP | Placebo comparator | Drug: SalinePatients receiving late CABG >7 days of the cessation of clopidogrel, treated with placebo(saline solution) |
| group BT | Experimental | Drug: Tranexamic AcidPatients receiving CABG without preoperative clopidogrel exposure, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery. |
| group BP | Placebo comparator | Drug: SalinePatients receiving CABG without preoperative clopidogrel exposure, treated with placebo(saline solution) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring primary and isolated coronary artery bypass grafting with cardiopulmonary bypass
Key exclusion criteria (5 listed)
- history of cardiac surgery
- hematocrit <33%
- platelet count <100,000/ml
- allergy to tranexamic acid
- recruited in other studies
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 AcidA bolus of 10 mg/kg after anesthetic induction over 10 min followed by a maintenance of 10 mg/kg/h for the duration of surgery | Drug | group BT, group ET, group LT |
| SalineSaline served as placebo | Drug | group BP, group EP, group LP |
Primary outcome
Postoperative blood loss(chest drainage)
Time frame: on the 120th day postoperatively
Incidence of major bleeding
Time frame: on the 120th day postoperatively
RBC Transfusion (volume and rate)
Time frame: on the 120th day postoperatively
2 secondary outcomes
Mortality
Time frame: on the 120th day postoperatively
Major morbidity
Time frame: on the 120th day postoperatively
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 22 Nov 2011.
- Derived from this study: PubMed 23426385Shi J, Ji H, Ren F, Wang G, Xu M, Xue Y, Chen M, Qi J, Li L. Protective effects of tranexamic acid on clopidogrel before coronary artery bypass grafting: a multicenter randomized trial. JAMA Surg. 2013 Jun;148(6):538-47. doi: 10.1001/jamasurg.2013.1560.
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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.
Lihuang Li, MD study chair
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Jia Shi, MD principal investigator
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid and Saline in people with Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 7 sites 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 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 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
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?
Postoperative blood loss(chest drainage) (time frame: on the 120th day postoperatively). The study lists 3 primary outcomes in all. 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 NCT01060163, 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 22 Nov 2011.