| CTRI Number |
CTRI/2026/03/106018 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study Comparing Two Durations (6 Weeks vs 3 Months) of Blood Thinner Treatment for Blood Clots in Children Aged 1 Month to 18 Years |
|
Scientific Title of Study
|
Comparative Effectiveness of 6 Weeks vs 3 Months of Anticoagulation Therapy in pediatric patient admitted with provoked DVT in tertiary care center |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dinesh Kumar Yadav |
| Designation |
professor Pediatrics |
| Affiliation |
Dr RML Hospital and ABVIMS |
| Address |
Department of Pediatrics
Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9868143132 |
| Fax |
|
| Email |
dineshkumar169@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
MANJU NIMESH |
| Designation |
Specialist Paediatrics |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital |
| Address |
Department of Pediatrics
Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital
New Delhi
DELHI
110001
India |
| Phone |
09891220132 |
| Fax |
|
| Email |
manjulhmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MANJU NIMESH |
| Designation |
Specialist Paediatrics |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital |
| Address |
Department of Pediatrics
Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital
New Delhi
DELHI
110001
India |
| Phone |
09891220132 |
| Fax |
|
| Email |
manjulhmc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Pediatrics |
| Address |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr RML Hospital New Delhi |
| 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 |
| MANJU NIMESH |
Dr Ram Manohar Lohia Hospital |
Department of Pediatrics
Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital
ABVIMS& Dr RML Hospital New Delhi
New Delhi
DELHI |
09891220132
manjulhmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee PGIMER Dr RML Hospital New Delhi. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I828||Embolism and thrombosis of other specified veins, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
6 Weeks vs 3 Months of Anticoagulation Therapy in paediatric patient with provoked DVT admittted in a tertiary care centre |
Children aged 1 month to 18 years admitted with a first episode of provoked DVT in Ward, PICU, HDU, confirmed by imaging (Doppler ultrasonography, CT, or MRI venography), will be eligible for enrollment.
Initial (Acute) Therapy
• Low Molecular Weight Heparin (LMWH): Enoxaparin subcutaneously every 12 hours to for 5 days.
• 1 mg/kg/dose subcutaneous 2 months, 1.5mg/kg/dose in children 1 month -2 months
Sub-Acute / Maintenance Therapy-
• Direct oral anticoagulants (DOACs) Rivaroxaban will be prescribed as oral anticaogulant, monitored, and adjusted according to best clinical practice.
AT end of 6 weeks
USG Doppler to check resolution and stop treatment in group A (Complete resolution) continue therapy in group B(partial Resolution) and C (No Resolution)
Week 12
USG Doppler to check resolution and stop treatment in group group B and C
Weekly followup Physicaly/Telephonicaly for compliance, bleeding any untowards complications
Month 4,5,6,7,8
2 /4 Weekly followup Physicaly/Telephonicaly for bleeding risk, resurrence, PTS assessment
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Provoked DVT
Radioimaging confirmed acute DVT
Informed consent from guardian |
|
| ExclusionCriteria |
| Details |
Prior VTE
Active malignancy
SLE or any rheumatological condition
Planned thrombolysis
Major thrombophilia
Active bleeding or high bleeding risk or platelet count less than 50000
Severe hepatic or renal dysfunction
Refusal of consent
Ongoing risk factor requiring prolonged anticoagulation
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage reduction in thrombus size from baseline
Complete vs partial vs no resolution
|
Percentage reduction in thrombus size from baseline
Complete vs partial vs no resolution at 6 week and 12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of new thrombotic events during treatment and up to 6 months post therapy confirmed by USG
Bleeding Episodes using International Society on Thrombosis and Haemostasis criteria
Post-Thrombotic Syndrome measured using Modified Villalta Score |
At 6 months monthly follow up after therapy
|
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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)
|
23/03/2026 |
| 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 Applicable |
| 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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [manjulhmc@gmail.com].
- For how long will this data be available start date provided 28-01-2029 and end date provided 28-12-2032?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The proposed research aims to generate population-specific prospective evidence to inform individualized evidence based treatment decisions for children with provoked DVT by comparing 6 week and 3 months anticoagulation regimens The study seeks to determine whether a shorter treatment duration yields comparable thrombus resolution and safety outcomes without increasing the risk of recurrence or bleeding or post thrombotic syndrome If found non inferior a shorter regimen may reduce treatment burden cost and psychosocial stress for patients and families. |