| CTRI Number |
CTRI/2024/02/062944 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Platelet Indices in Dengue Fever |
|
Scientific Title of Study
|
Platelet Count And Platelet Indices As Predictor Of Severity Of Dengue Fever - A Cross Sectional 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 |
Dr. Kanika Paul |
| Designation |
Junior resident |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room no. 1162 Department of Pathology Rohilkhand Medical College and Hospital Pawan Vihar
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8588002654 |
| Fax |
|
| Email |
kpaul1130@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mithila Bisht |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Department Of Pathology Rohilkhand Medical College and Hospital, Pawan Vihar, Bareilly, Uttar Pradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7906080213 |
| Fax |
|
| Email |
dr.mithila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Kanika Paul |
| Designation |
Junior resident |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room no. 148 Third Floor AC Girls Hostel Rohilkhand Medical College and Hospital Pawan Vihar
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8588002654 |
| Fax |
|
| Email |
kpaul1130@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr. Kanika Paul |
| Address |
Room no. 63 Third Floor AC GIRLS HOSTEL, Rohilkhand Medical College and Hospital Pawan Vihar Bareilly Uttar Pradesh |
| Type of Sponsor |
Other [Self] |
|
|
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 Kanika Paul |
Rohilkhand Medical College and Hospital |
Room no. 1162 Department of Pathology Rohilkhand Medical College and Hospital Pawan Vihar
Bareilly
UTTAR PRADESH |
8588002654
kpaul1130@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RMCH, Bareilly, U.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B338||Other specified viral diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with fever and diagnosed as Dengue Positive.
Dengue positive patients with thrombocytopenia |
|
| ExclusionCriteria |
| Details |
Patients who have other proven causes of thrombocytopenia and fever.
Patients with co-infection such as Malaria
Patients on anti-epileptic drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To categorize dengue positive patients according to platelet counts
To determine platelet indices of the patients.
To correlate the platelet count with the mean value of platelet indices |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To categorize dengue positive patients according to platelet counts
To determine platelet indices of the patients.
To correlate the platelet count with the mean value of platelet indices |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
02/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/03/2024 |
| 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)
|
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 - NO
|
|
Brief Summary
|
This study will be conducted in RMCH, Bareilly and will include all dengue positive patients in the hospital during the study period after taking approval from the Institutional Ethics Committee and consent from the patient. Blood will be collected in EDTA vacutainer, by using disposable needle and syringe, under aseptic conditions, with proper labels. After proper mixing of the sample, it will be run in the haematology analyzer (SYSMEX XN-550) for complete cell counts along with platelet indices. Patients with thrombocytopenia will be divided into 3 groups: Group 1: Platelet Count <20,000 Group 2: Platelet Count 20,000-1,00,000 Group 3: Platelet Count 1,00,000-1,50,000 Then all the platelet indices i.e. MPV, PDW, Plateletcrit (PCT), and Platelet Count (PC) will be documented. |