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CTRI Number  CTRI/2024/12/078593 [Registered on: 26/12/2024] Trial Registered Prospectively
Last Modified On: 25/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   The Impact of Platelet-Rich Plasma (PRP) on the Maturation Rates of Arteriovenous Fistulas in End-Stage Renal Disease Patients 
Scientific Title of Study   Evaluation of the role of Platelet rich plasma in overall success rates of AV fistula in patients with End stage renal disease A randomized 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  Pranjal Chowdhury 
Designation  Senior Resident (Academic) Urology 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Urology, 2nd floor, AIIMS bhubaneswar, Sijua, Patrapada
Bhangagarh
Khordha
ORISSA
751019
India 
Phone  8472046025  
Fax    
Email  pc12376@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manoj Kumar Das 
Designation  Thesis guide 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Urology 2nd floor AIIMS Bhubaneswar Sijua Patrapada

Khordha
ORISSA
751019
India 
Phone  7894453494  
Fax    
Email  urol_manoj@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Manoj Kumar Das 
Designation  Thesis guide 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Urology 2nd floor AIIMS Bhubaneswar Sijua Patrapada

Khordha
ORISSA
751019
India 
Phone  7894453494  
Fax    
Email  urol_manoj@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Orissa 751019 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  AIIMS bhubaneswar, Sijua, Patrapada Bhubaneswar, 751019 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pranjal Chowdhury   AIIMS Bhubaneswar  Department of urology 2nd floor, AIIMS Bhubaneswar, Room 240
Khordha
ORISSA 		 8472046025

pc12376@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee AIIMS bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group Placebo control group  In this group no PRP would be added after AV fistula creation  
Intervention  Platelet rich plasma group  Local application Platelet rich plasma in wound bed after AV fistula creation. . AV fistula creation takes around 45 mins. PRP will be applied to wound bed before skin closure. Hence duration of exposure would be around 30 mins to 1 hour.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusion criteria include age over 18 years with ESRD requiring hemodialysis. 
 
ExclusionCriteria 
Details  Critical thrombocytopenia (low platelet count)
Hypofibrinogenaemia
Haemodynamic instability (collapse)
Acute and chronic infections
Chronic liver disease
Anti-coagulation therapy (warfarin, dabigatran, heparin)
Platelet dysfunction syndrome
Local infection at the site of the procedure
Hemodialysis port on the Same side

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Two co-primary end points
1. AVF diameter
2. AVF blood flow 		 Measured at 4th , 6th and 12 th week after AVF creation 
 
Secondary Outcome  
Outcome  TimePoints 
Time to successful cannulation
Time to initiation of Hemodialysis.
Stenosis rate (at anastomotic site or distal to it).
Complication rates (Bleeding, thrombosis, infection, Aneurysm formation, presence of steal phenomenon).
 		 Measured at 4th , 6th and 12 th week after AVF creation 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   11/01/2025 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pc12376@gmail.com].

  6. For how long will this data be available start date provided 11-01-2025 and end date provided 11-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The hall mark of End-stage renal disease (ESRD) is  a progressive decline of kidney function.

 Despite the advancements in hemodialysis techniques, the success rates of AVFs, a preferred method for Vascular access, remain suboptimal, with some studies reporting only 50 to 61 % success rates. In the quest for improving AVF outcomes, one promising direction in tissue healing is the application of platelet-rich plasma (PRP). It stimulates cellular pathways necessary for tissue regeneration, making it an attractive option for enhancing the success of AVF creation. This study aims to explore the impact of PRP on improving primary patency rates in patients undergoing AVF creation for ESRD. By leveraging the regenerative properties of PRP, this research seeks to provide a viable solution to enhance the success rates of AVFs, thereby improving the overall management and quality of life for ESRD patients. 
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