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A Clinical Study to Compare Two Different Methods of Using The Drug Tranexamic Acid To Reduce Bleeding In Patients Undergoing Cardiac Valve Replacement Surgeries

Comparison of The Efficacy and Safety of Intravenous Versus Topical Tranexamic Acid in Patients Undergoing Cardiac Valve Replacement Surgeries- A Randomized Control Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021376
Enrollment
80
Registered
2019-09-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I359- Nonrheumatic aortic valve disorder, unspecified Health Condition 2: I349- Nonrheumatic mitral valve disorder, unspecified Health Condition 3: I369- Nonrheumatic tricuspid valve disorder, unspecified Health Condition 4: I069- Rheumatic aortic valve disease, unspecified Health Condition 5: I089- Rheumatic multiple valve disease,unspecified

Interventions

Intervention1: Intravenous Tranexamic Acid: Efficacy of Intravenous Tranexamic Acid with respect to blood loss and requirement of blood transfusion. Tranexamic Acid will be given at a dose of 15mg/kg

Sponsors

SRM Medical College Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Elective Surgeries 2.Cardiac Valve Replacement or Repair 3.ASA I-III

Exclusion criteria

Exclusion criteria: 1.Emergency surgeries 2.Re-do surgeries 3.Renal Insufficiency(Creatinine >1.8) 4.Hepatic Insufficiency(Direct Bilirubin >2.0) 5.Pre-existing coagulopathy 6.Pre-existing Deep vein thrombosis/Pulmonary embolism 7.Patients on anticoagulant medications (within 5 days before surgery)

Design outcomes

Primary

MeasureTime frame
To evaluate the amount of blood lossTimepoint: upto 48 hours—

Secondary

MeasureTime frame
Requirement of blood transfusions and incidence of side effectsTimepoint: Upto 5 days post-operatively—

Countries

India

Contacts

Public ContactKARTHIKA URKAVALAN

SRM MEDICACL COLLEGE AND RESEARCH CENTER

gayathrii.r@gmail.com9500092905

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026