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CTRI Number  CTRI/2025/12/098268 [Registered on: 01/12/2025] Trial Registered Prospectively
Last Modified On: 28/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A study to understand how blood and blood products are used for the treatment of critically ill patients in the Intensive Care Unit 
Scientific Title of Study   Blood and blood product transfusion practices in critically ill patients: A prospective 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  Joshita S Singh 
Designation  Junior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Anaesthesia and Intensive Care Nehru hospital Level 4
Sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  8054113800  
Fax    
Email  joshitasingh25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Neeru Sahni 
Designation  Additional Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Anaesthesia and Intensive Care Nehru hospital Level 4
Sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9872646106  
Fax    
Email  neerunalin@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Neeru Sahni 
Designation  Additional Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Anaesthesia and Intensive Care Nehru hospital Level 4
Sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9872646106  
Fax    
Email  neerunalin@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, Level 4, Nehru hospital, Postgraduate Institution of Medical Education and Research Chandigarh 160012 India 
 
Primary Sponsor  
Name  Postgraduate Institution of Medical Education and Research 
Address  Department of Anaesthesia and Intensive Care, Level 4, Nehru hospital, Block A, Chandigarh, 160012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Joshita S Singh  Main ICU, Nehru hospital, PGIMER  Main ICU, Nehru hospital, Level 2, A block, Postgraduate Institute of Medical Education and Research, Chandigarh, India 160012
Chandigarh
CHANDIGARH 
8054113800

joshitasingh25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research, Institutional Ethics Committee (Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D50-D53||Nutritional anemias, (2) ICD-10 Condition: D65-D69||Coagulation defects, purpura and other hemorrhagic conditions, (3) ICD-10 Condition: D70-D77||Other disorders of blood and blood-forming organs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All adult patients admitted to the main ICU during the study period will be enrolled on the day of admission. 
 
ExclusionCriteria 
Details  1. Patients with duration of stay less than 48 hours
2. Patients with known haematological disorder
3. Refusal to participate 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Thresholds for transfusion of various blood products  Baseline and daily 
 
Secondary Outcome  
Outcome  TimePoints 
To analyse the consistency of transfusion practices with available guidelines   Baseline & daily 
To correlate the association of transfusion with clinical outcomes (length of stay in ICU & hospital, days of mechanical ventilation, requirement of renal replacement therapy, vasopressor requirement, ICU mortality) & TRALI & TACO (as diagnosed by the clinical team)   Baseline & daily 
To analyse the incidence of anaemia in critically ill patients (Hb 12 gm per dl for females & 14 gm per dl for males)  
Baseline & daily 
To analyse average Hb in critically ill patients adjusted for the number of PRBC units transfused & duration of ICU stay  Baseline & daily 
To analyse the volume of blood sampled each day (routine & on-demand) & its correlation with anaemia  Baseline & daily 
To analyse the frequency of reports of laboratory investigations (haemogram & coagulogram) within the normal range  Baseline & daily 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   09/12/2025 
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 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  

Introduction

Transfusion of blood and blood products is a common intervention in the intensive care unit (ICU). In the face of haemodynamic instability, anaemia, coagulopathy, or bleeding, the decision to transfuse is often made in real time. However, variability exists in practicedue to differing patient-specific factors, availability of blood products, and clinician preferences. Critically ill patients often develop anaemia due to frequent blood sampling, underlying inflammation, and bleeding, increasing the likelihood of transfusion.

Various authors have reported inconsistent adherence to the currently available evidence-based guidelines.

While blood products can be life-saving, their use may contribute to adverse outcomes, increased length of ICU stay, and complications such as transfusion reactions, volume overload, and immunomodulation. Evaluating current practices through the lens of thresholds and clinical reasoning is essential to identify the gaps between evidence and clinical practice.

This study aims to assess blood and blood product transfusion practices in the ICU setting, with focus on component-specific utilisation, thresholds and reasons for transfusion.

 Research question

Blood and blood product transfusion practices in the ICU in terms of thresholds and reasons for the same

P: All adult patients admitted to the Main ICU

E: Blood and/or blood product transfusion

O: Thresholds and reasons for the decision to transfuse

T: Duration of ICU stay


 Objectives

Primary outcome: Thresholds and reasons for transfusion of various blood products.

Secondary outcomes:

Consistency of transfusion practices with available guidelines.

Association of transfusion with clinical outcomes (LOS in ICU, days of mechanical ventilation, requirement of RRT, vasopressor requirement, ICU mortality) and TRALI and TACO (as diagnosed by the clinical team).

Incidence of anaemia in critically ill patients. (Hb 12-14gm/dl for females and 14-16gm/dl for males)

Average Hb in critically ill patients adjusted for the number of PRBC units transfused and duration of ICU stay.

Volume of blood sampled each day (routine and on-demand) and its correlation with the incidence of anaemia.

Frequency of reports of laboratory investigations (Hmg and coagulogram) within normal range.

 

Study Design: Prospective, observational study

Setting: Main ICU, PGIMER, Chandigarh

Duration Of Study: One year from date of Ethics Committee approval and CTRI registration (200 patients)

Inclusion criteria: All adult patients admitted to Main ICU will be enrolled on the day of admission. These will be the medically critically ill patients.

Exclusion Criteria:

Patients with duration of stay < 48 hours

Patients with known haemotological disorder (malignancy etc.)

Refusal to participate

 

Methodology

Data Collection:

Baseline parameters

Demographic data (age, gender, body weight, height)

Provisional diagnosis

APACHE II score on Day 1

Charlson Comorbidity index (CCI)

SOFA score on Day 1

Daily Hb and coagulogram

Transfusion-related data

Blood and blood product transfusion: day of admission

Type and volume of blood product transfused

Threshold and reason for transfusion

Day-wise blood sampling volume (routine or on-demand)

Use of haematinics/iron/EPO (daily)

Any bleeding episode

Normal reports of laboratory investigations (haemogram and coagulogram)

Clinical outcome data

Length of stay (LOS) in ICU

Days of mechanical ventilation

Daily number of inotropes

Requirement of renal replacement therapy (RRT)

ICU mortality

LOS in hospital

In-hospital mortality

 

Sample size calculation:

In the previous year, the Main ICU admitted 326 patients. We plan to recruit 200 patients consecutively over the duration of the study (1 year).

Data Analysis:

Descriptive analysis will be done, the categorical variables will be expressed as frequencies and percentages, and continuous variables will be expressed as mean ± SD or median and Inter-quartile range.

Predefined subgroups identified will be patients undergoing transfusion or not, according to each blood product, patient comorbidity profile and organ dysfunction at the time of admission.

Comparison between various subgroups will be done using t-test, Fisher’s exact test, Mann-Whitney test, etc., as appropriate.

 

 

 

 

 

 
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