Coronary Artery DiseaseNCT01596738
Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation
A study testing Tranexamic Acid and Saline in people with Coronary Artery Disease and Coronary Artery Bypass Graft, run by Li Lihuan at 1 site in China.
Trial summary
The use of platelet aggregation inhibitors, including aspirin and clopidogrel, 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, Coronary Artery Bypass Graft
- What is being tested?
- Tranexamic Acid and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to Mar 2012
- 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
- Men and women aged 18-85 years undergoing primary and isolated on-pump CABG
- Last ingestion of clopidogrel and aspirin within 7 days preoperatively
Who cannot join
- Previous cardiac surgery
- Hematocrit <33%
- Platelet count <100,000/ml
- Allergy to tranexamic acid
- Recruited in other studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tranexamic Acid in Patients Receiving Primary and Isolated On-pump CABG With Premature Clopidogrel Cessation to Reduce Postoperative Bleeding and Transfusion
The use of platelet aggregation inhibitors, including aspirin and clopidogrel, 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.
Tranexamic acid is a widely used antifibrinolytic agent, and is a promising substitute for aprotinin when the latter has been suspended in 2007.The release of plasmin during 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.
Read more
Many studies and meta-analyses have shown a reduction in postoperative bleeding and transfusion requirements of this antifibrinolytic drug in cardium revascularization surgery. Unfortunately the preoperative antiplatelet therapy was either neglected or obscure. Few studies specify the time between the last clopidogrel ingestion and surgery.Several studies were keen on the blood loss and allogeneic transfusion in patients who received their last clopidogrel or asprin within 7 days prior to coronary artery bypass grafting. Concerning the secession 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 less than 7 days prior to surgery. The working hypothesis is that tranexamic acid would reduce bleeding and transfusion requirements in this specific population of patients.
- Being tested
- Tranexamic Acid, Saline
- Keywords
- Coronary Artery Disease, Coronary Artery Bypass Graft, Platelet Aggregation Inhibitors, Tranexamic Acid
- 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
- Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction
- Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization
SalineDrug
- Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction
- Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid group | Experimental | 1. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction
2. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization Receives: Drug: Tranexamic Acid |
| Placebo group | Placebo comparator | 1. Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction
2. Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allogeneic erythrocyte, volume transfused
Total volume of allogeneic erythrocyte transfused, from the beginning of the operation until discharge
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Allogeneic erythrocyte, percentage exposed
The percentage of patients exposed to allogeneic erythrocyte, from the beginning of the operation until discharge
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcomes (3)
Blood loss
The total volume of chest drainage from the end of the operation until the removal of the drainage tube
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Major bleeding
The incidence of major bleeding according to the CURE definition
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Reoperation
The incidence of reoperation for excessive bleeding
Measured: Participants will be followed for the duration of hospital stay, an expected 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 posted11 May 2012 (estimated)
- Study startOct 2008
- Primary completionMar 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Li Lihuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Lihuan, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Lihuan Li, M.D., Principal investigator, Cardiovascular Institute and Fuwai Hospital, NCCD, PUMC & CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596738
- Sponsor's protocol ID
- Fuwai2008
- Status last verified
- May 2012
- First submitted
- 5 May 2012
- Last updated
- 11 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in Patients Receiving Primary and Isolated On-pump CABG With Premature Clopidogrel Cessation to Reduce Postoperative Bleeding and Transfusion
- ClinicalTrials.gov ID
- NCT01596738
- Acronym / sponsor ID
- Fuwai2008
- Keywords
- Coronary Artery Disease, Coronary Artery Bypass Graft, Platelet Aggregation Inhibitors, Tranexamic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Li LihuanUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 May 2012 (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, 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.
Tranexamic acid is a widely used antifibrinolytic agent, and is a promising substitute for aprotinin when the latter has been suspended in 2007.The release of plasmin during 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.
Many studies and meta-analyses have shown a reduction in postoperative bleeding and transfusion requirements of this antifibrinolytic drug in cardium revascularization surgery. Unfortunately the preoperative antiplatelet therapy was either neglected or obscure. Few studies specify the time between the last clopidogrel ingestion and surgery.Several studies were keen on the blood loss and allogeneic transfusion in patients who received their last clopidogrel or asprin within 7 days prior to coronary artery bypass grafting. Concerning the secession 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 less than 7 days prior to surgery. The working hypothesis is that tranexamic acid would reduce bleeding and transfusion requirements in this specific population of patients.
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 Acid1. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction 2. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization |
| Placebo group | Placebo comparator | Drug: Saline1. Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction 2. Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women aged 18-85 years undergoing primary and isolated on-pump CABG
- Last ingestion of clopidogrel and aspirin within 7 days preoperatively
Key exclusion criteria (5 listed)
- Previous 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 Acid1. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction 2. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization | Drug | Tranexamic Acid group |
| Saline1. Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction 2. Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization | Drug | Placebo group |
Primary outcome
Allogeneic erythrocyte, volume transfused
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Total volume of allogeneic erythrocyte transfused, from the beginning of the operation until discharge
Allogeneic erythrocyte, percentage exposed
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
The percentage of patients exposed to allogeneic erythrocyte, from the beginning of the operation until discharge
3 secondary outcomes
Blood loss
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Major bleeding
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Reoperation
Time frame: Participants will be followed for the duration of hospital stay, an expected 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 11 May 2012.
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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. principal investigator
Cardiovascular Institute and Fuwai Hospital, NCCD, PUMC & CAMS
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 and Saline in people with Coronary Artery Disease and Coronary Artery Bypass Graft, run by Li Lihuan 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 2 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 11 May 2012. 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?
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?
Allogeneic erythrocyte, volume transfused (time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days). 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 11 May 2012.