| CTRI Number |
CTRI/2022/12/048107 [Registered on: 14/12/2022] Trial Registered Prospectively |
| Last Modified On: |
25/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Is Dabigatran better than aspirin in preventing blood clots in deep veins after fractures of the pelvis and acetabulum |
|
Scientific Title of Study
|
Randomised Control Trial to Compare efficacy of Dabigatran versus Aspirin in Prevention of Venous Thromboembolism in Pelvic and Acetabular injuries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chinmoy Sharma |
| Designation |
Resident |
| Affiliation |
Ganga Medical Centre and Hospitals Pvt Ltd |
| Address |
Department of Orthopaedics
Traumatology division
Room no. - OP1
Ganga Medical Centre and Hospitals Pvt Ltd,
313, Mettupalayam Road,
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
7002069547 |
| Fax |
|
| Email |
drchinmoysharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Agraharam |
| Designation |
Consultant |
| Affiliation |
Ganga Medical Centre and Hospitals Pvt Ltd |
| Address |
Department of Orthopaedics
Traumatology division
Room no. - OP1
Ganga Medical Centre and Hospitals Pvt Ltd,
313, Mettupalayam Road,
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9994399441 |
| Fax |
|
| Email |
agraharamdevendra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chinmoy Sharma |
| Designation |
Resident |
| Affiliation |
Ganga Medical Centre and Hospitals Pvt Ltd |
| Address |
Department of Orthopaedics
Traumatology divison
Room no. OP1
Ganga Medical Centre and Hospitals Pvt Ltd,
313, Mettupalayam Road,
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
7002069547 |
| Fax |
|
| Email |
drchinmoysharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga Medical Centre and Hospitals Pvt Ltd
313, Mettupalayam Road
Coimbatore
Pincode 641043
Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Chinmoy Sharma |
| Address |
Ganga Medical Centre and Hospitals Pvt Ltd
313, Mettupalayam Road
Coimbatore
641043
Tamilnadu |
| Type of Sponsor |
Other [Self] |
|
|
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 Chinmoy Sharma |
Ganga Medical Centre and Hospital Pvt Ltd. |
Ganga Medical centre and Hospital Pvt Ltd.
Department of Orthopaedics
Orthopaedic Trauma Division
Room No. - 1
Coimbatore
TAMIL NADU |
7002069547
drchinmoysharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review board - Orthopaedics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I824||Acute embolism and thrombosis of deep veins of lower extremity, (2) ICD-10 Condition: S329||Fracture of unspecified parts of lumbosacral spine and pelvis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aspirin |
Dose - 150 mg
Frequency - once daily
Route- Oral
Duration - 6 weeks |
| Intervention |
Dabigatran Etexilate |
Dose - 110 mg
Frequency - twice daily
Route- Oral
Duration - 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Pelvic and Acetabular fractures above 18 years of age, treated surgically or conservatively and requiring 6 weeks or more of immobilization will be included in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients below 18 years of age
2. Patients with open injuries of the lower limb requiring external fixators/soft tissue cover in the form of grafts/flaps which precludes compression stockings application will be excluded.
3. Patients with Bilateral/contralateral lower limb injuries
4. Patients with concomitant head/ abdominal injury requiring intervention
5. Patients with previous history of Venous Thromboembolism, coagulopathies, malignancy,
6. Patients with Impaired Kidney function
7. Patients with previous non ambulatory status,
8. Patients on anticoagulant therapy
9. Patients who do not consent for the study will be excluded
10. Patients lost to follow up will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary/Main outcome - The incidence of Deep vein thrombosis in patients treated with eithe Dabigatran or Aspirin |
DVT will be assessed by venous doppler at 6 weeks and 12 weeks from date of surgery or date of trauma( if treated conservatively) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome would be the incidence of major bleeding events in either of the two categories. Major bleeding events means the requirement of surgical intervention |
Major bleeding event would normally follow up at our hospital. Or else it will be assessed at 6 weeks and 12 weeks follow up if managed in other hospitals |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/12/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drchinmoysharma@gmail.com].
- For how long will this data be available start date provided 20-11-2022 and end date provided 20-11-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
AIM OF STUDY To assess and compare the efficacy and safety of Dabigatran and Aspirin in prevention of Venous Thromboembolism in Pelvic and Acetabular injuries OBJECTIVES 1. To compare the effectiveness of Dabigatran and Aspirin in preventing Symptomatic or Asymptomatic Deep vein Thrombosis . 2. To compare the safety of Dabigatran and Aspirin in terms of major post-surgical haemorrhage. Hypothesis - Dabigatran is more effective than aspirin in preventing Thromboembolism
|