Back to resultsDose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery
Primary Purpose
Thromboses, Deep Vein, Tranexamic Acid Adverse Reaction
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Thromboses, Deep Vein focused on measuring dose effect, tranexamic acid, deep vein thromboses
Eligibility Criteria
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
Sites / Locations
- Chinese Academy of Medical Sciences， Fuwai Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Dose group 1
Dose group 2
Dose group 3
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
The incidence of deep venous thrombosis
Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound
Secondary Outcome Measures
The rate of new-onset thrombotic events
Thrombotic events include ischemic stroke, renal failure, myocardial infarction and pulmonary embolism
The rate of allogeneic RBC transfusion
Allogeneic blood product includes packed red blood cell
The volume of allogeneic RBC transfusion
Allogeneic blood product includes packed red blood cell
Length of stay in ICU and hospital
The time interval between the end of the operation and the discharge from ICU or the hospital.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03838328
Brief Title
Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery
Official Title
Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery With Cardiopulmonary Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
February 28, 2020 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
SHI Jia
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboses, Deep Vein, Tranexamic Acid Adverse Reaction
Keywords
dose effect, tranexamic acid, deep vein thromboses
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The allocation is masked for the participant, care provider, investigator and outcomes assessor.
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose group 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose group 3
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
Primary Outcome Measure Information:
Title
The incidence of deep venous thrombosis
Description
Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound
Time Frame
Within 7 days postoperatively
Secondary Outcome Measure Information:
Title
The rate of new-onset thrombotic events
Description
Thrombotic events include ischemic stroke, renal failure, myocardial infarction and pulmonary embolism
Time Frame
Within 90 days postoperatively
Title
The rate of allogeneic RBC transfusion
Description
Allogeneic blood product includes packed red blood cell
Time Frame
Within 30 days postoperatively
Title
The volume of allogeneic RBC transfusion
Description
Allogeneic blood product includes packed red blood cell
Time Frame
Within 30 days postoperatively
Title
Length of stay in ICU and hospital
Description
The time interval between the end of the operation and the discharge from ICU or the hospital.
Time Frame
Within 90 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Shi, M.D.
Phone
86 10 88322467
Email
shiandypumc@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Shi, M.D.
Organizational Affiliation
Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences， Fuwai Hospital
City
Beijing
ZIP/Postal Code
100037
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery
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