Thromboses, Deep Vein, Tranexamic Acid Adverse Reaction
Conditions
Keywords
dose effect, tranexamic acid, deep vein thromboses
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.
Interventions
DRUGTranexamic Acid
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
Sponsors
SHI Jia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The allocation is masked for the participant, care provider, investigator and outcomes assessor.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of deep venous thrombosis | Within 7 days postoperatively | Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of new-onset thrombotic events | Within 90 days postoperatively | Thrombotic events include ischemic stroke, renal failure, myocardial infarction and pulmonary embolism |
| The rate of allogeneic RBC transfusion | Within 30 days postoperatively | Allogeneic blood product includes packed red blood cell |
| The volume of allogeneic RBC transfusion | Within 30 days postoperatively | Allogeneic blood product includes packed red blood cell |
| Length of stay in ICU and hospital | Within 90 days postoperatively | The time interval between the end of the operation and the discharge from ICU or the hospital. |
Countries
China
Contacts
Primary ContactJia Shi, M.D.
Outcome results
None listed