| CTRI Number |
CTRI/2025/08/093226 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
17/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Low Platelet Counts in Critically Ill Sepsis Patients: Insights from a Hospital-Based Study |
|
Scientific Title of Study
|
New-onset thrombocytopenia in critically ill sepsis patients: A cross-sectional observational 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 |
Shreya Sharma |
| Designation |
Junior Resident |
| Affiliation |
Sharda School of Medical Sciences & Research |
| Address |
Sharda University, Knowledge Park-III, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
01204622999 |
| Fax |
|
| Email |
shreyikashami@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ram Murti Sharma |
| Designation |
Professor |
| Affiliation |
Sharda School of Medical Sciences & Research |
| Address |
Dept. of Anaesthesia, Sharda University, Knowledge Park-III, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
01204622999 |
| Fax |
|
| Email |
ram.sharma1@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Shreya Sharma |
| Designation |
Junior Resident |
| Affiliation |
Sharda School of Medical Sciences & Research |
| Address |
Sharda University, Knowledge Park-III, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
01204622999 |
| Fax |
|
| Email |
shreyikashami@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
School of Medical Sciences Research Sharda University |
| Address |
Dept. of Anaesthesia, Sharda Hospital & Research Centre, Greater Noida |
| Type of Sponsor |
Private 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 Shreya Sharma |
Sharda Hospital & Research Center |
Dept. of Anaesthesia, Division 2F, 2nd floor, School of Medical Sciences & Research Sharda University, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
8588840390
shreyikashami@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sharda Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, (2) ICD-10 Condition: D696||Thrombocytopenia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All adult of both genders patients with sepsis based on SOFA score |
|
| ExclusionCriteria |
| Details |
Patients’ attendant refusing consent or
patients with hematological malignancies and pregnant patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluating the prevalence of thrombocytopenia in sepsis patients |
0, 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identifying risk factors for thrombocytopenia in sepsis patients |
1 year |
| Identifying the causes of thrombocytopenia in sepsis patients |
1 year |
| Assessing the outcome of patients with sepsis |
1 year |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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)
|
30/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study aims to evaluate the prevalence, risk factors, causes, and outcomes of new-onset thrombocytopenia among ICU patients with sepsis. Thrombocytopenia, defined as a platelet count below 150,000/mm³, is a frequent hematological abnormality in critically ill patients, particularly in sepsis, with an incidence ranging from 13% to 60%. It can result from decreased platelet production, increased destruction, or sequestration, and in septic patients, is associated with poor prognosis including higher acute kidney injury rates, prolonged vasopressor use, extended ICU stays, major bleeding, and increased mortality. The study will be conducted from June 2025 to December 2026 in the ICU of Sharda Hospital as a hospital-based cross-sectional observational study. Based on prior research indicating a 47% incidence in septic patients, the calculated sample size is 95 patients. Adults over 18 years with sepsis, as defined by SOFA score criteria, will be included, while patients who refuse consent, those under 18, with hematological malignancies, or who are pregnant will be excluded. Data will be collected through daily evaluations, CBC with platelet count monitoring, sepsis severity scoring, assessment of organ dysfunctions, infection source identification, medication review, and outcome measures including ICU stay, ventilation duration, and mortality. Ethical clearance has been obtained, informed consent will be taken from legal representatives, and participation will be free of cost, with minimal risk from blood sampling. Previous literature, such as Venkata et al. (2013) and Sharma et al. (2007), has shown high thrombocytopenia incidence in septic patients and strong associations with worse outcomes, with unresolved thrombocytopenia significantly increasing mortality. This study seeks to further clarify these associations and identify key predictors in the local ICU population.
|