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CTRI Number  CTRI/2026/01/100186 [Registered on: 02/01/2026] Trial Registered Prospectively
Last Modified On: 02/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to assess the number of patients admitted to the ICUs that develops anemia and what are the factors that causes anemia in these participants and the outcome of the participants  
Scientific Title of Study   An observational study to assess the proportion and determinants of anemia and outcomes among critically ill patients admitted to the intensive care units (ICUs) of a tertiary care hospital in Udupi District. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neesha Mohamed 
Designation  Nurse Practitioner student 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Medical Surgical Nursing, Manipal College of Nursing, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  96115159964  
Fax    
Email  neesha.mohamed1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Soumya Christabel 
Designation  Associate Professor 
Affiliation  Manipal college of Nursing, MAHE 
Address  Department of Medical Surgical Nursing, Manipal College of Nursing, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9739319382  
Fax    
Email  soumya.christabel@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Soumya Christabel 
Designation  Associate Professor 
Affiliation  Manipal college of Nursing, MAHE 
Address  Department of Medical Surgical Nursing, Manipal College of Nursing, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9739319382  
Fax    
Email  soumya.christabel@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal, Karnataka, 576104 
 
Primary Sponsor  
Name  Kastuba Hospital, Manipal 
Address  Kasturba Hospital Manipal, Karnataka, India, 576104 
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 
Neesha Mohamed  Kasturba Hospital   Intensive care units, Kasturba Hospital, MAHE, Madhav Nagar, Manipal, 576104
Udupi
KARNATAKA 		 9611515964

neesha.mohamed1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KasturbaMedicalCollegeAndKasturbaHospitalInstitutionalEthicsCommittee-2StudentResearch  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D695||Secondary thrombocytopenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  • patients who are directly admitted to the ICUs
• patients who are above 18 years of age
• patients who have a change in the class of anemia
i.e: patients who have mild anemia on admission developing moderate or severe anemia by 72 hours of ICU admission
 
 
ExclusionCriteria 
Details  1 patients with hematological malignancies
2 patients with chronic kidney disease
3. patients who are transferred to the ICUs from another hospital

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Identify the proportion of patients that develops anemia within 3 days of ICU admission
• identify the factors that causes anemia among critically ill patients
• identify the outcomes of patients that develop anemia in terms of their:
o length of ICU/Hospital stay
o in hospital mortality
o need for blood product transfusion

 		 • Identify the proportion of patients that develops anemia within 3 days of ICU admission
• identify the factors that causes anemia among critically ill patients
• identify the outcomes of patients that develop anemia in terms of their:
o length of ICU/Hospital stay
o in hospital mortality
o need for blood product transfusion

 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="384"
Sample Size from India="384" 
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)   18/01/2026 
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="0"
Months="6"
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  

While it is evident that anemia is common among critically ill patients, the outcomes of patients that develop anemia during the course of illness remains underexplored. Moreover, the mechanism of anemia development among ICU critically ill patients also remains understudied. This research will try to study the effect that anemia has on the outcomes in the critically ill patients on the basis of their length of stay and the in hospital mortality as well as their status at discharge from the ICU. Furthermore, the study will also shed some light on the factors that leads to development of anemia among the patients admitted to ICUs and their etiopathogenesis.

 
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