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CTRI Number  CTRI/2020/12/029747 [Registered on: 11/12/2020] Trial Registered Prospectively
Last Modified On: 01/05/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Desmopressin nasal spray to decrease the bleeding complications in percutaneous kidney biopsy 
Scientific Title of Study   Desmopressin nasal spray to decrease the bleeding complications in percutaneous kidney biopsy: a randomized controlled trial 
Trial Acronym  DESMOPRESSIN-BIOPSY Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vineet Behera 
Designation  Nephrologist 
Affiliation  Dept of Internal Medicine, INHS Asvini 
Address  Nephrologist, Dept of Internal Medicine, INHS Asvini, Colaba

Mumbai
MAHARASHTRA
400005
India 
Phone  02222143992  
Fax    
Email  vineetbeheraaiims@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vineet Behera 
Designation  Nephrologist 
Affiliation  Dept of Internal Medicine, INHS Asvini 
Address  Nephrologist, Dept of Internal Medicine, INHS Asvini, Colaba

Mumbai
MAHARASHTRA
400005
India 
Phone  02222143992  
Fax    
Email  vineetbeheraaiims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vineet Behera 
Designation  Nephrologist 
Affiliation  Dept of Internal Medicine, INHS Asvini 
Address  Nephrologist, Dept of Internal Medicine, INHS Asvini, Colaba

Mumbai
MAHARASHTRA
400005
India 
Phone  02222143992  
Fax    
Email  vineetbeheraaiims@gmail.com  
 
Source of Monetary or Material Support  
INHS Asvini, Colaba, Mumbai 
 
Primary Sponsor  
Name  Department of Nephrology INHS Asvini 
Address  INHS Asvini, Colaba, Mumbai, Maharashtra 400005 
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 Vineet Behera  Renal Care Unit, Dept of Nephrology, INHS Asvini  Colaba, Mumbai
Mumbai
MAHARASHTRA 
02222143992

vineetbeheraaiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC INHS Asvini, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N17-N19||Acute kidney failure and chronic kidney disease, (2) ICD-10 Condition: N00-N08||Glomerular diseases, (3) ICD-10 Condition: N10-N16||Renal tubulo-interstitial diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Arm  Saline nasal spray 4 puff given 30 min before renal biopsy 
Intervention  Desmopressin Arm  Desmopressin nasal spray 4 puff given 30 min before renal biopsy 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Blood pressure < 140/90 mmHg
2. Normal coagulation parameters and platelet count
 
 
ExclusionCriteria 
Details  Graft kidney biopsy, Patients on antiplatelets, Poorly controlled hypertension, Hydro/pyonephrosis, Any form of coagulation disorder
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Post-biopsy Bleeding Complications, Presence of hematoma and its size   12 hours and 24 hours after biopsy 
 
Secondary Outcome  
Outcome  TimePoints 
Variation in blood pressure 12 hours before and upto 24 hour after kidney biopsy
 
24 hours after biopsy 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   12/12/2020 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Renal biopsy is an essential procedure in the diagnosis of primary and secondary renal diseases. The technique has significantly improved over the past two decades because of the introduction of ultrasonography and automated-gun biopsy devices; however an accurate clinical, chemistry and renal ultrasound evaluation before and 24-hours post renal biopsy is necessary, because bleeding complications still occur in about 1/3 of our procedures, with major complications occurring in only 1.2% of patients. 

Desmopressin (DDAVP) is a synthetic derivative of the anti-diuretic hormone vasopressin; therefore, the administration of DDAVP is often accompanied by water retention, a drop in blood pressure and a secondary increase in heart rate. The haemostatic effect of DDAVP is related to an increase of vWF-factor VIII levels. DDAVP is the treatment of choice for most patients with von Willebrand (type I) disease and haemophilia A; moreover, the compound has been shown to be useful in a variety of inherited and acquired hemorrhagic conditions, including, chronic liver disease, uremia, and haemostatic defects induced by the therapeutic use of anti-thrombotic drugs such as aspirin and ticlopidine. Finally, DDAVP has been used as a haemostatic agent in patients undergoing surgery at major risk of bleeding. Few studies have used desmopressin  before kidney biopsy to reduce the chances of hematoma or other bleeding complications. However, the majority of published studies are retrospective and non-randomized, and there is paucity of high grade evidence of the role of desmopressin in preventing post renal biopsy bleeding complications.

 

The aim of this study is to evaluate the effect of pre-biopsy treatment with desmopressin nasal spray  on the incidence of post-biopsy bleeding complications.

 
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