| CTRI Number |
CTRI/2025/07/091707 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two doses of aspirin for preventing blood clots after hip and knee replacement surgery |
|
Scientific Title of Study
|
A Randomized Controlled Trial Comparing the Efficacy and Safety of Aspirin 75 mg vs. Aspirin 150 mg for Venous Thromboembolism (VTE) Prophylaxis in Patients Undergoing Total Hip and Knee Arthroplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahil Sanghavi |
| Designation |
Principal Investigator, Consultant Orthopedic Surgeon |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabilitation |
| Address |
Sancheti Institute for Orthopedics and Rehabilitation
11,12 Shivajinagar, Pune 411005
Sancheti Institute for Orthopedics and Rehabilitation
SIOR, Main building, 1st floor, OPD 1,room no 5,6
Pune
MAHARASHTRA
411005
India |
| Phone |
9921522220 |
| Fax |
|
| Email |
sahil.sanghavi@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sahil Sanghavi |
| Designation |
Principal Investigator, Consultant Orthopedic Surgeon |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabilitation |
| Address |
Sancheti Institute for Orthopedics and Rehabilitation
11,12 Shivajinagar, Pune 411005
Sancheti Institute for Orthopedics and Rehabilitation
SIOR, Main building, 1st floor OPD 1, room no 5,6
Pune
MAHARASHTRA
411005
India |
| Phone |
9921522220 |
| Fax |
|
| Email |
sahil.sanghavi@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sahil Sanghavi |
| Designation |
Principal Investigator, Consultant Orthopedic Surgeon |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabilitation |
| Address |
Sancheti Institute for Orthopedics and Rehabilitation
11,12 Shivajinagar, Pune 411005
Sancheti Institute for Orthopedics and Rehabilitation
SIOR, Main building, 1st floor OPD 1, room no 5,6
Pune
MAHARASHTRA
411005
India |
| Phone |
9921522220 |
| Fax |
|
| Email |
sahil.sanghavi@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopedics and Rehabilitation |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopaedics and Rehabilitation |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation
11,12 Thube Park, Shivajinagar, Pune 411005 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr sahil sanghavi |
Sancheti Hospital, Pune, Maharashtra, India |
11,12 Thube Park, Shivajinagar, Pune 411005, SIOR Main building 1st floor OPD 1, Room No 5,6,Hip+Knee department
Pune
MAHARASHTRA |
9921522220
sahil.sanghavi@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sancheti Institute for Orthopedics and Rehabilitation, shivajinagar pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M16||Osteoarthritis of hip, (2) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aspirin 150 mg |
Aspirin 150 mg tablet, administered orally once daily for 4 weeks postoperatively for VTE prophylaxis in patients undergoing total hip and knee arthroplasty |
| Intervention |
Aspirin 75 mg |
Aspirin 75 mg tablet, administered orally once daily for 4 weeks postoperatively for VTE prophylaxis in patients undergoing total hip and knee arthroplasty. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults undergoing primary total hip or knee arthroplasty
2. No prior history of DVT or VTE
3. Willing to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Active bleeding disorders or peptic ulcer disease
2. History of stroke, recent myocardial infarction (MI), or severe renal or liver dysfunction
3. Patients on chronic anticoagulant therapy
4. Patients undergoing partial hip or knee replacement
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of symptomatic venous thromboembolism (VTE) within 90 days postoperatively |
Incidence of symptomatic venous thromboembolism (VTE) within 90 days postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Incidence of major, minor bleeding events |
At baseline, 4 weeks, 12 weeks |
| 2.Rate of early periprosthetic joint infection |
At baseline, 4 weeks, 12 weeks |
| 3. Gastrointestinal complications ,all couse mortality |
At baseline, 4 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized controlled trial to compare the efficacy and safety of Aspirin 75 mg versus Aspirin 150 mg for venous thromboembolism (VTE) prophylaxis in patients undergoing primary total hip and knee arthroplasty. The study aims to determine if low-dose aspirin is as effective as a higher dose in preventing VTE, while also evaluating bleeding risks and early post-operative complications. A total of 3,000 patients will be enrolled and randomized into two groups. The study is currently in the pre-recruitment phase. |