| CTRI Number |
CTRI/2025/03/081827 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Development, of a tool for predicting bleeding in patients with Dengue fever for optimizing transfusion therapy in Dengue |
|
Scientific Title of Study
|
Development, validation and real-world impact of bleeding prediction models for optimizing transfusion therapy in Dengue |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rachana |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Emergency Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9599460465 |
| Fax |
|
| Email |
rachana2806@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Gupza |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Infectious Diseases, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9868996079 |
| Fax |
|
| Email |
nityanitingupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rachana |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Emergency Medicine, Kasturba Medical College, Manipal
KARNATAKA
576104
India |
| Phone |
9599460465 |
| Fax |
|
| Email |
rachana2806@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V Ramalingaswamy Bhavan, PO box 9941, Ansari Nagar, New Delhi -110029, India |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Indian Council of Medical Research, V Ramalingaswamy Bhavan, PO box 9941, Ansari Nagar, New Delhi -110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Rachana |
Kasturba Hospital, Manipal |
Department of Emergency Medicine, Kasturba Medical College, Manipal -576104
Udupi
KARNATAKA |
9599460465
rachana2806@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College & Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A90||Dengue fever [classical dengue], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bleeding Prediction tool incoporating Thromboelastography test |
The bleeding prediction tool will be designed using statistical modelling of the phase 1 data collection which may include Laboratory test results such as platelet count ,Hematocrit, PT, aPTT, or Thromboelastography test results values.(currently not a part of the standard of care) |
| Comparator Agent |
Nil (Current standard of care) |
The comparison arm will not have any bleeding prediction tool. The treating physician may use test such as platelet count or PT/INR as per current practice or standard of care to predict bleeding and decide on transfusion therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with Fever with Thrombocytopenia and having positive Dengue card test (NS1/IgM) on screening |
|
| ExclusionCriteria |
| Details |
Known coagulation disorder
Patient on anticoagulant medications
Patients with active bleeding at the time of admission |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bleeding (except petechiae & minor mucosal bleed) |
48 hours from recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood Product transfusion (RDP) |
48 hours from recruitment |
|
|
Target Sample Size
|
Total Sample Size="918"
Sample Size from India="918"
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 3 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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="4"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study will be a diagnostic randomised trial. A bleeding prediction tool to predict 48-hour bleeding in Dengue. The treating Physician in the Diagnostic intervention arm will be given the bleeding prediction tool, the control group will not be provided the bleeding prediction tool and will receive the standard of care as per the treating physician. The incidence of 48 hour bleeding, blood product transfusion practices will be noted. The bleeding prediction tool will be validated and its real-world impact and physician acceptance will be studied. |