A Phase 4 interventional study of Tranexamic Acid in Thromboses, Deep Vein and Tranexamic Acid Adverse Reaction, sponsored by SHI Jia. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-02-12.
Sponsored by SHI Jia · Phase 4, Interventional, and Treatment
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.
787 studies on the registry are indexed under Venous Thrombosis; 123 are open to participants now.
This study's planned enrollment of 360 is above the median of 131 across 463 interventional studies indexed under Venous Thrombosis.
Browse Venous Thrombosis studies →SHI Jia is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Drug: Tranexamic Acid
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.
Drug: Tranexamic Acid
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.
Drug: Tranexamic Acid
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
The incidence of deep venous thrombosis
Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound
Time frame: Within 7 days postoperatively
The rate of new-onset thrombotic events
Thrombotic events include ischemic stroke, renal failure, myocardial infarction and pulmonary embolism
Time frame: Within 90 days postoperatively
The rate of allogeneic RBC transfusion
Allogeneic blood product includes packed red blood cell
Time frame: Within 30 days postoperatively
The volume of allogeneic RBC transfusion
Allogeneic blood product includes packed red blood cell
Time frame: Within 30 days postoperatively
Length of stay in ICU and hospital
The time interval between the end of the operation and the discharge from ICU or the hospital.
Time frame: Within 90 days postoperatively
Plan to share: No
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This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid
SHI Jia