- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03838328
Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery
February 9, 2019 updated by: SHI Jia
Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery With Cardiopulmonary Bypass
In recent years, the lysine analogs tranexamic acid (TXA) has gained wide use in cardiac surgery as a blood-sparing agent.
However, the safety of the drug and its impact on overall outcomes of cardiac surgery remains debated.
The current study evaluates the dose effect of TXA on the incidence of deep venous thrombus (DVT) in cardiac surgery with cardiopulmonary bypass.
Also, the dose effect of TXA on bleeding and allogeneic transfusion is evaluated.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
360
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jia Shi, M.D.
- Phone Number: 86 10 88322467
- Email: shiandypumc@sina.com
Study Locations
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Beijing, China, 100037
- Chinese Academy of Medical Sciences, Fuwai Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients receiving selective cardiac surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
- Written consent obtained
Exclusion Criteria:
- Allergy or contraindication to tranexamic acid
- Severe renal impairment (serum creatinine >250 μmol/l, or estimated creatinine clearance <25 ml/min)
- Thromboembolic disease including but not limited to: history of pulmonary embolism, spontaneous arterial thrombosis or familial hypercoaguability (eg. Lupus anticoagulant, protein C deficiency)
- Thrombocytopenia defined as a platelet count <100,000/ml
- Coagulopathy defined as an international normalized ratio > 1.5 prior to surgery
- Currently enrolled in another perioperative interventional study
- Pregnancy or lactation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose group 1
The dose regimen of tranexamic acid in group 1 includes a loading dose of 30mg/kg before skin incision and a maintenance dose of 20mg/kg/hr until the end of the operation.
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Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
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Experimental: Dose group 2
The dose regimen of tranexamic acid in group 2 includes a loading dose of 20mg/kg before skin incision and a maintenance dose of 15mg/kg/hr until the end of the operation.
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Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
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Active Comparator: Dose group 3
The dose regimen of tranexamic acid in group 3 includes a loading dose of 10mg/kg before skin incision and a maintenance dose of 10mg/kg/hr until the end of the operation.
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Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of deep venous thrombosis
Time Frame: Within 7 days postoperatively
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Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound
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Within 7 days postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of new-onset thrombotic events
Time Frame: Within 90 days postoperatively
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Thrombotic events include ischemic stroke, renal failure, myocardial infarction and pulmonary embolism
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Within 90 days postoperatively
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The rate of allogeneic RBC transfusion
Time Frame: Within 30 days postoperatively
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Allogeneic blood product includes packed red blood cell
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Within 30 days postoperatively
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The volume of allogeneic RBC transfusion
Time Frame: Within 30 days postoperatively
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Allogeneic blood product includes packed red blood cell
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Within 30 days postoperatively
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Length of stay in ICU and hospital
Time Frame: Within 90 days postoperatively
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The time interval between the end of the operation and the discharge from ICU or the hospital.
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Within 90 days postoperatively
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jia Shi, M.D., Fuwai Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2019
Primary Completion (Anticipated)
February 28, 2020
Study Completion (Anticipated)
March 31, 2020
Study Registration Dates
First Submitted
February 1, 2019
First Submitted That Met QC Criteria
February 9, 2019
First Posted (Actual)
February 12, 2019
Study Record Updates
Last Update Posted (Actual)
February 12, 2019
Last Update Submitted That Met QC Criteria
February 9, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dose effect of TA on DVT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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