| CTRI Number |
CTRI/2026/01/100520 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Efficacy of Arteriovenous Fistula (AVF) Creation for Hemodialysis Access — Using vs Not Using Subcutaneous Low-Molecular-Weight Heparin (LMWH) for kidney failure patients |
|
Scientific Title of Study
|
Comparison of Efficacy of Arteriovenous Fistula (AVF) Creation in Chronic Renal Failure for Hemodialysis Access — Using vs Not Using Subcutaneous Low-Molecular-Weight Heparin (LMWH): A Randomized Controlled 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 |
Dharmendra Kumar Pipal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
OPD room No. 101, Department of General Surgery, All India Institute of Medical Sciences, Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
09602541730 |
| Fax |
|
| Email |
dr.dharmendrapipal2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dharmendra Kumar Pipal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
OPD room No. 101, Department of General Surgery, All India Institute of Medical Sciences, Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
09602541730 |
| Fax |
|
| Email |
dr.dharmendrapipal2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dharmendra Kumar Pipal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
OPD room No. 101, Department of General Surgery, All India Institute of Medical Sciences, Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
09602541730 |
| Fax |
|
| Email |
dr.dharmendrapipal2007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
kunra ghat, Gorakhpur, uttar pradesh, India
Pin code 273008 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dharmendra Kumar Pipal |
All India Institute of Medical Sciences |
OPD room No. 101, Department of General Surgery
Gorakhpur
UTTAR PRADESH |
09602541730
dr.dharmendrapipal2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC/AIIMS-GKP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (2) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: (n=30, LMWH) |
They will be scheduled to receive perioperative subcutaneous injection of LMWH (Enoxaparin sodium) 60mg/0.6ml prior to surgery and another dose 12 hr after
the surgery .
|
| Comparator Agent |
Group B: (n=30, No LMWH) |
They will be scheduled not to receive perioperative subcutaneous injection of LMWH
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18 years to 75 yrs of age with stage 4 or 5 CKD.
Patients with systolic B.P. more than 100 mmHg
Suitable vascular anatomy confirmed by doppler usg arterial and venous diameter more than 2 mm.
Stable cardiovascular status
• No history of previous AV fistula creation in intended arm
|
|
| ExclusionCriteria |
| Details |
Previous vascular surgery on target arm
Inadequate arteries or veins for fistula creation (eg: severe stenosis, occlusion, calcification).
H/O injection or blood sampling or injection in the arm where av fistula is to be created
Patients with connective tissue disorders , vasculitis.
• BMIs below 18.5 or above 29.9
• Pregnant and breastfeeding women were not allowed to participate
• Peripheral vascular diseases in the intended arm.
• Severe uncontrolled comorbidities like: heart failure, coagulopathy, bleeding disorders, severe diabetes with advanced neuropathy or poor wound healing.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the patency rate of AVFs at 6 weeks between patients receiving perioperative LMWH and those not receiving LMWH.
|
6 weeks after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the incidence of early AVF thrombosis (within 30 days) in both groups.
To evaluate & compare perioperative bleeding & hematoma formation associated with LMWH use.
To determine the need for re-intervention within 3 months after AVF creation.
To compare patency at 3 months between the two groups.
To assess access-related infections within the first 3 months postoperatively.
To evaluate serious adverse events or complications associated with perioperative LMWH.
|
. Early thrombosis within 4 weeks of surgery
. Other complications in 12 weeks of surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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="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
|
Arteriovenous fistula (AVF) creation is the preferred vascular access for hemodialysis, yet early failure rates remain high—often 20–50 percent—mainly due to early thrombosis and poor maturation. These complications delay effective dialysis, increase reliance on temporary catheters, and lead to higher morbidity and healthcare costs. Low-molecular-weight heparin (LMWH) may reduce perioperative thrombosis by improving vessel patency during the critical early postoperative period. However, existing evidence is limited, inconsistent, and lacks rigorous randomized trials, particularly regarding safety concerns such as bleeding or hematoma formation. A well-designed randomized controlled study is therefore necessary to determine whether perioperative LMWH can improve early AVF patency and maturation without increasing complications. This trial aims to generate reliable data to guide clinical practice and optimize outcomes for patients requiring hemodialysis access. |