| CTRI Number |
CTRI/2026/02/103286 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparative study between saphenous vein and polytetrafluoroethylene loop graft as a conduit for haemodialysis. |
|
Scientific Title of Study
|
Comparative study in terms of their potency between the use of saphenous vein graft and polytetrafluoroethylene loop graft in forearm as an access for hemodialysis in chronic kidney disease patients :A pilot study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pardeep Kumar |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
CTVS department ,Aiims Rishikesh.
Rishikesh.
CTVS department ,AIIMS Rishikesh. Rishikesh.
Dehradun
UTTARANCHAL
249201
India |
| Phone |
8082328133 |
| Fax |
|
| Email |
residentpardeep07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pardeep Kumar |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
CTVS department ,AIIMS Rishikesh.
RISHIKESH.
CTVS department AIIMS Rishikesh, Rishikesh.
Dehradun
UTTARANCHAL
249201
India |
| Phone |
8082328133 |
| Fax |
|
| Email |
residentpardeep07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pardeep Kumar |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
CTVS department ,AIIMS Rishikesh.
Rishikesh.
CTV department ,AIIMS Rishikesh .
Rishikesh.
Dehradun
UTTARANCHAL
249201
India |
| Phone |
8082328133 |
| Fax |
|
| Email |
residentpardeep07@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh , Rishikesh.
Pin Code 249201
India . |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Pardeep Kumar |
Rishikesh AIIMS |
CTVS department.
Dehradun
UTTARANCHAL |
8082328133
residentpardeep07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aiims Rishikesh Institutionaal ethics committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Forearm straight saphenous vein graft for hemodialysis |
straight saphenous vein graft from radial artery to brachial vein in forearm will used and primary and secondary outcome observed. |
| Comparator Agent |
Forearm Polytetrafluroethylene graft for hemodialysis . |
Polytetrafluroethylene loop graft between brachial l artery and brachial vein will be used and primary and secondary outcome measured |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
88.00 Year(s) |
| Gender |
Both |
| Details |
All the patients requiring hemodialysis and does not have good size superficial veins / or have exhausted superficial veins.
Willing / Consent to participate in this study
|
|
| ExclusionCriteria |
| Details |
Patients having diseased / severely atherosclerotic radial / brachial artery.
Patients having severe varicosities of veins.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare primary and secondary patency rate in both the groups after 4 weeks,24 weeks and 48 weeks of formation.It is a main outcome used to determine the effect of investigation. |
To compare primary and secondary patency rate in both the groups after 4 weeks, 24 weeks, and 48 weeks of formation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the total surgical time in both the groups .
2. To compare the pseudoaneurysm formation of the access site in both the group during one year of follow up.
|
immediate post operative period.
30 days ,six months and one year . |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
19/02/2026 |
| 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="2"
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
|
: This study is clinical trail and it will be 2 year long prospective observational pilot study in which patients will be studied in two groups, one group will be PTFE group and other group will be straight saphenous vein group. After obtaining IEC clearance, those patients satisfying the inclusion criteria will be included in the study. Patients will then be taken up for surgery where duration of the surgery will be noted. After that patients will be followed by clinical examination and USG Doppler at 1 months, 6 months and 1 year for primary and secondary patency or any signs of pseudoaneurysm/aneurysm formation |