Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery
NCT ID: NCT03838328
Last Updated: 2019-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
360 participants
INTERVENTIONAL
2019-03-01
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Tranexamic Acid
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
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.
Tranexamic Acid
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
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.
Tranexamic Acid
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
Interventions
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Tranexamic Acid
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
Eligibility Criteria
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Inclusion Criteria
* Written consent obtained
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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SHI Jia
OTHER
Responsible Party
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SHI Jia
Associate Professor and Vice Chair of the Anesthesiology Department
Principal Investigators
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Jia Shi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Chinese Academy of Medical Sciences， Fuwai Hospital
Beijing, , China
Countries
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Central Contacts
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Other Identifiers
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Dose effect of TA on DVT
Identifier Type: -
Identifier Source: org_study_id
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