| 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
|
|
|
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
|
|
|
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. |