comparison of two blood clotting drugs

Phase 4

Conditions: Health Condition 1: M170- Bilateral primary osteoarthritis of kneeHealth Condition 2: M170- Bilateral primary osteoarthritis of knee

Registration Number: CTRI/2020/09/027667

Lead Sponsor: Deepak Bansal

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Eligible for this study were patients who were undergoing a primary elective bilateral total knee arthroplasty for a diagnosis of osteoarthritis

Exclusion Criteria

Patients were excluded for any of the following: (1) an allergy to Tranexamic acid ; (2)preoperative hepatic or renal dysfunction; (3) serious cardiac or respiratory disease, including coronary artery stent placement;

(4) congenital or acquired coagulopathy, as evidenced by an international normalized ratio (INR) of >1.4 or a partial thromboplastin time (PTT) of >1.4 times normal; (5)thrombocytopenia, as identified by a preoperative platelet

count of <150,000/mm3; (6) history of a prothrombotic condition; (7) pregnancy; (8) breastfeeding; (9) donated preoperative

autologous blood; (10) diagnosis of inflammatory arthritis; (11) an age of <18 years or >100 years; and/or (12) a preoperative hemoglobin level of <10 g/dL.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measures were perioperative calculated <br/ ><br>blood loss, total drain output at 24 hours, and perioperative <br/ ><br>blood transfusion rate. The calculated blood loss was determined <br/ ><br>from the difference between the preoperative hemoglobin <br/ ><br>level and the lowest postoperative hemoglobin level <br/ ><br>during the hospital stay (or prior to transfusion, if applicable)Timepoint: The primary outcome measures were perioperative calculated <br/ ><br>blood loss, total drain output at 24 hours, and perioperative <br/ ><br>blood transfusion rate. The calculated blood loss was determined <br/ ><br>from the difference between the preoperative hemoglobin <br/ ><br>level and the lowest postoperative hemoglobin level <br/ ><br>during the hospital stay (or prior to transfusion, if applicable)

Secondary Outcome Measures

Name	Time	Method
secondary outcomes <br/ ><br>included an analysis of complications, namely symptomatic <br/ ><br>VTE, cerebrovascular accident, and arterio-occlusive <br/ ><br>events (such as myocardial infarction).Timepoint: 24 hours