Role of Tranexamic acid in reducing blood loss in total hip replacement surgeries

Not yet recruiting

• Conditions: Joint derangement, unspecified,

• Registration Number: CTRI/2018/08/015421
• Lead Sponsor: AIIMS Raipur

Brief Summary

This is a randomized controlled blinded trial comparing the efficacy and safety of single dose IV tranexamic acid in one arm comprising of 63 subjects in each arm) with that of IV plus single postoperative IV dose of tranexamic acid with regards to drop in hematocrit after 24 hours, requirement of blood transfusion after 24 hours as the primary outcome in our institution over a period of one year. The secondary outcomes of the study will include a possible decrease in inflammatory markers like IL 6 & D-Dimer after 12 hours, the length of hospital stay and complications if any in the hospital.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-08-17
• Study Start: 2018-08-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

Adult patients, 18 – 65 years of either sex with ASA grade I and II undergoing primary elective unilateral hip joint arthroplasty by same surgeon.

Exclusion Criteria

• Patients with a) The absence of written informed consent b) Bilateral arthroplasties c) Complicated primary total hip arthroplasty with previous osteotomy, simultaneous fracture fixation, implant removal or bone grafting, History of thromboembolic diseases, d) The presence of clotting disorder or current treatment with an antiplatelet agent, anticoagulant or deep vein thrombosis (DVT) prophylaxis in the perioperative period, e) Renal disease f) History of the previous allergy to TXA.
• g) History of labile or uncontrolled hypertension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a.Drop in Hct after 24 hours	Pre-op Hb/Hct: | Post-op Hb/Hct: | Immediately after surgery: | 24 hours after surgery: | 48 hours after surgery: | Drain output: | 3 hours after surgery: | 6 hours after surgery: | 12 hours after surgery: | 24 hours after surgery:
b.Blood transfusion requirement in the first 24 hours	Pre-op Hb/Hct: | Post-op Hb/Hct: | Immediately after surgery: | 24 hours after surgery: | 48 hours after surgery: | Drain output: | 3 hours after surgery: | 6 hours after surgery: | 12 hours after surgery: | 24 hours after surgery:

Secondary Outcome Measures

Name	Time	Method
c.Decrease in inflammatory markers (IL6 and D-dimer) after 12 hours compared to the baseline	d.Complications if any during the stay in hospital

Trial Locations

Locations (1)

AIIMS, Raipur; 🇮🇳 Raipur, CHHATTISGARH, India

AIIMS, Raipur

🇮🇳Raipur, CHHATTISGARH, India

Dr Subrata Kumar Singha

Principal investigator

8518881767

subratsingh@gmail.com