| CTRI Number |
CTRI/2025/02/079981 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
study to see the effect of post operative systemic anticoagulation in patients undergoing post traumatic medium sized vessel repair. |
|
Scientific Title of Study
|
A Randomised Controlled Trial To See The Effect Of Post- Operative Systemic Anticoagulation In Patients Undergoing Post Traumatic Medium Sized Vessel Repair |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushma Sagar |
| Designation |
Professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Division of Trauma Surgery and Critical Care
JPN Apex Trauma Centre AIIMS
NEW DELHI 110029
Central
DELHI
110029
India |
| Phone |
9891510122 |
| Fax |
|
| Email |
sagar.sushma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Sagar |
| Designation |
Professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Division of Trauma Surgery and Critical Care
JPN Apex Trauma Centre AIIMS
NEW DELHI 110029
Central
DELHI
110029
India |
| Phone |
9891510122 |
| Fax |
|
| Email |
sagar.sushma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ram Krishna Kumar |
| Designation |
senior resident |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Division of Trauma Surgery and Critical Care
JPN Apex Trauma Centre AIIMS
NEW DELHI 110029
Central
DELHI
110029
India |
| Phone |
7992208030 |
| Fax |
|
| Email |
rkk14519891@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aiims |
| Address |
Aiims, Sri Aurobindo Marg, Ansari Nagar East
New Delhi 110029 |
| 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 Ram Krishna Kumar |
Jai Prakash Narayan Apex Trauma Center, Aiims |
Division of Trauma Surgery
2nd floor
JPNATC,
Ring Road, Raj Nagar, Safdurgung enclave, New Delhi, 110029
Central
DELHI |
7992208030
rkk14519891@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Postgraduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S451||Injury of brachial artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Randomised heparin administration |
Based on the randomisation group a will receive intravenous heparin in post op period for 72 hours while group b will not receive heparin and their outcome will be compared |
| Intervention |
Randomised heparin administration |
Based on the randomisation, group a will receive heparin and group b will not receive heparin in post operative period. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with medium size vessel injury(4-8mm) includes Axillary artery, Brachial Artery,Femoral artery and Popliteal artery |
|
| ExclusionCriteria |
| Details |
Patients with head injuries.
Pregnant Females.
Patients already on Anticoagulation.
Venous/Prosthetic graft repair.
Contraindication of Anticoagulation due to associated injuries/Co-morbidities including CAD, Ischaemic heart disease, Stroke, Coagulopathies etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of post operative systemic anticoagulation in terms of patency of medium size peripheral arterial repair in a vascular trauma |
To assess the effect of post operative systemic anticoagulation in terms of patency of medium size peripheral arterial repair in a vascular trauma on post operative day 02 and just bedore discharge or on day 05 whichever is later |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess complications like
Post operative bleeding
Re-exploration,
Blood products required
Limb loss
Length of hospital stay on pod2, pod5 & at 6 weeks with the use of post operative systemic anticoagulation in medium sized arterial repair |
at baseline
on post op day 02
on post op day 05
at 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="205"
Sample Size from India="205"
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 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="1"
Months="9"
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
|
Those Patients Who Will be Operated for definitive arterial repair will be included in the study considering in lusion and exclusion criteria, informed consent will be obtained, patient will be randomised in two groups, both groups will receive intra-op bolus heparin 80IU/KG Body weight. In post op period, group A will receive maintenance i.v heparin 18 IU/KG For 3 days while group B will not receive any systemic Anticoagulation in post op period.colour Doppler will be scheduled at post op day 2 and 5 OR Earlier in case of absent peripheral pulse in operated limb. Outcome measures: patency of the repaired artery as measured by Doppler Study at an interval of 48 hours and 5th post op day or at the time of discharge whichever is later. Signs of bleeding requiring re-exploration or blood products transfusion. Re-exploration will be decided after consultation with treating faculty. |