| CTRI Number |
CTRI/2025/04/086038 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study comparing medicines to prevent blood clots in patients with spinal cord injury causing paralysis |
|
Scientific Title of Study
|
Comparison of different deep venous thrombosis pharmacological prophylaxis in paraplegic patients due to spinal cord injury an exploratory trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Utsav anand |
| Designation |
Junior resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
All India Institute of Medical Sciences Rishikesh Virbhardra Marg
Rishikesh Dehradun Uttarakhand
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9870631269 |
| Fax |
|
| Email |
utsavanand17808@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pankaj Kandwal |
| Designation |
Professor and Head of Department |
| Affiliation |
AIIMS Rishikesh |
| Address |
All India Institute of Medical Sciences Rishikesh
Dehradun Uttarakhand
Dehradun
UTTARANCHAL
249201
India |
| Phone |
8475000282 |
| Fax |
|
| Email |
pankaj.orth@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Utsav anand |
| Designation |
Junior resident |
| Affiliation |
|
| Address |
All India Institute of Medical Sciences Rishikesh
Dehradun Uttarakhand
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9870631269 |
| Fax |
|
| Email |
utsavanand17808@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Rishikesh Dehradun Uttarakhand India Postal code: 249201 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
Virbhadra Marg Rishikesh Dehradun Uttarakhand PIN code 249201 |
| Type of Sponsor |
Government medical college |
|
|
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 Utsav Anand |
All India Institute of Medical Sciences Rishikesh |
Orthopaedic ward Level 5 Block C Hospital wing AIIMS Rishikesh Virbhadra Marg Rishikesh Dehradun Uttarakhand PIN code 249201 India
Dehradun
UTTARANCHAL |
9870631269
utsavanand17808@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M45-M49||Spondylopathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aspirin |
150 mg Once a day Per oral for 3 months |
| Comparator Agent |
Dabigatran |
110 mg Once a day Per oral for 3 months |
| Intervention |
Medical drug intervention |
Nil |
| Comparator Agent |
Rivaroxaban |
10 mg Once a day Per oral for 3 months |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with
ASIA A neurology
ASIA B neurology
FRENKEL A neurology
FRENKEL B neurolog
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of ASPIRIN , DABIGATRAN AND RIVAROXABAN which can be used as DVT prophylaxis in paraplegic patient with spinal cord injury using components of ultrasound examination of vein viz grey scale ( whether there is compression or not ) and doppler ( whether there is colour filling or not ) using CFV , SFV and popliteal vein screening |
at 14 days , 45 days , 90 days postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study cost effective analysis between aspirin , dabigatran , rivaroxaban in paraplegic patient due to spinal cord injury
To study effect of aspirin , dabigatran and rivaroxaban over CRPH , D-dimer , ESR
To compare the outcome of operated patients with time of intervention
To find out incidence of DVT in indian population in each ( aspirin , dabigatran and rivaroxaban group) |
at 14 days , 45 days , 90 days postoperatively |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
13/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Direct oral anticoagulants (DOACs) have been found to be more effective in recent research, particularly when used in orthopedic populations or as a preventative measure in rehabilitation centers. Anticoagulants are one of the most important medication which are always prescribed in paraplegic patients to avoid one of the most dreadest complication i.e. DVT. Today we have options of antiplatelets ( like COX inhibitors , PDE inhibitors , ADP P2Y12 antagonist , GP IIB/IIIA anatgonist ) and anticoagulants (vit K inhibitor , factor Xa inhibitor , direct thrombin inhibitors , indirect thrombin inhibitors). There is lacunae in use of these medications in paraplegic patients due to spinal cord injury and also there effects in blood prameters like D-dimer , ESR and CRPH. Nevertheless, there are currently not enough data on SCI populations to support more suggestions. In this study we want to screen for deep venous thrombosis in paraplegic patients (whether its present or not ) using components of ultrasound examination of vein viz grey scale ( whether there is compression or not ) and doppler ( whether there is colour filling or not ) using CFV , SFV and popliteal vein screening |