Efficacy of perioperative Tranexamic Acid in patients undergoing trochanteric hip fracture surgery: A Randomized Placebo Controlled Trial.

Phase 3

Recruiting

• Conditions: blood loss; hip fracture surgery; Blood - Anaemia; Injuries and Accidents - Fractures; Surgery - Other surgery

• Registration Number: ACTRN12620001059954
• Lead Sponsor: Dr.Faaiz Ali Shah

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

1.Patients of either gender 18 years and above.
2. Trochanteric fracture types AO 31-A1, A2.
3.Received within one week after sustaining the fracture
4.American Society of Anesthesiologists (ASA) scores of I & II

Exclusion Criteria

1.Pre operative hemoglobin <10gm/dl.
2.Allergy to tranexamic acid
3.Severe dysfunction of heart, lung, liver, kidney, or coagulation.
4.Provoked deep venous thrombosis or pulmonary embolism within 30 days or myocardial infarction, cerebrovascular accident, or stent placement within 6 months.
5.Anticoagulant therapy such as antiplatelet drugs or warfarin before surgery.
6. Multiple fractures
7.Pathological fractures
8.Open fractures
9.Periprosthetic fractures
10.Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of blood transfusion from the time of surgery until discharge at 72 hours after surgery and will be checked from patient record.[ base line 24 hours before surgery,<br> 6 hours postoperatively,<br> 24 hours postoperatively.<br>48 hours post operatively,<br>and 72 hours post operatively. ]

Secondary Outcome Measures

Name	Time	Method
symptomatic DVT will be assessed with doppler ultrasound[ 2 weeks, 6 weeks, 3 months and 6 months after surgery];pulmonary embolism will be assessed with contrast computed tomography(CT) of chest.[2 weeks, 6 weeks, 3 months and 6 months after surgery];wound infection will be assessed by inspecting the incision site for redness, tenderness and discharge.Also laboratory tests namely complete blood count(BC),ertythrocyte Sedimintation Rate(ESR) and C Reactive Proteins(CRP) will be done to note any infection.[2 weeks, 6 weeks, 3 months and 6 months after surgery];Death of any patient during the follow up period if the patient did not attend the follow up date and confirmed with telephone or email.[2 weeks, 6 weeks, 3 months and 6 months after surgery]