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CTRI Number  CTRI/2024/05/068000 [Registered on: 28/05/2024] Trial Registered Prospectively
Last Modified On: 26/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Comparative Observational Study 
Study Design  Other 
Public Title of Study   Effect of blood transfusion in neurosurgical post operative patients in neuro ICU - An observational study 
Scientific Title of Study   Effect of blood transfusion on oxygen extraction ratio in postoperative neurosurgical ICU an 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  Dr Teena Stanly 
Designation  Post Graduate 
Affiliation  Yenepoya Medical College Hospital 
Address  Department of Anaesthesiology Yenepoya Medical College Yenepoya (Deemed to be) University Derlakatte Mangalore Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9663577824  
Fax    
Email  teena.stanly96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Smita Musti 
Designation  Associate Professor 
Affiliation  Yenepoya Medical College Hospital 
Address  Department of Anaesthesiology Yenepoya Medical College Yenepoya (Deemed to be) University Derlakatte Mangalore Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9886125842  
Fax    
Email  smitamusti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Smita Musti 
Designation  Associate Professor 
Affiliation  Yenepoya Medical College Hospital 
Address  Department of Anaesthesiology Yenepoya Medical College Yenepoya (Deemed to be) University Derlakatte Mangalore Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9886125842  
Fax    
Email  smitamusti@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Yenepoya Medical College and Hospital 
Address  Yenepoya Medical College Hospital Yenepoya (Deemed to be) University Yenepoya University Campus, Deralakatte Mangalore 575018 Karnataka India  
Type of Sponsor  Private medical college 
 
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 Teena Stanly  Yenepoya Medical College and Hospital   Neurosurgical ICU and ward Department of Anaesthesiology Yenepoya Medical College and Hospital, Yenepoya (Deemed to be) University Deralakatte Mangalore 575018 Karnataka
Dakshina Kannada
KARNATAKA 
9663577824

teena.stanly96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics Committee - 1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Age above 18 years
Glasgow coma scale 15
MAP>65 mmhg
Hourly urine output of 0.5ml/hr
Normothermia 
 
ExclusionCriteria 
Details  Pregnant women
Participants with parasympathetic hyperactivity
Participants with ongoing hemorrhage
Participants with renal failure
Participants with congestive cardiac failure
Participants without invasive lines - central line and arterial line
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To study the effect of blood transfusion on oxygen extraction ratio.
2. To compare the oxygen extraction ratio between the two groups.
 
Day zero 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the length of ICU stay in days in patients admitted to neuro ICU requiring blood transfusion
2. To assess Modified Rankin score at discharge from hospital.
 
30 days 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/06/2024 
Date of Study Completion (India) 07/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Blood transfusion is very often done in perioperative period for neurosurgical cases. Blood transfusion is not devoid of adverse reactions. Numerous criteria for blood transfusion have been published by various scientific societies with respect to neurosurgical cases. Literature of using physiological parameters as transfusion triggers in neurosurgical cases is limited. This study attempts to observe for change in oxygen extraction ratio following blood transfusion. Also, duration of ICU stay and Modified Rankin score will be noted. Postoperative neurosurgical patients admitted in neurocritical care unit requiring blood transfusion will be included in the study. Basic vital parameters like heart rate (HR), blood pressure (BP), saturation of peripheral oxygenation (SpO2), temperature will be noted from the monitor.  Haemoglobin, saturation of arterial oxygenation (Sa02), partial pressure of oxygen (Pa02), lactate and central venous oxygen saturation (ScVO2)will collected from the blood gas analysis report before transfusion. The same parameters will be collected 15mins after transfusion.  Total length of ICU stay in days will be noted and Modified Rankin Score at discharge will be recorded. Pre and post transfusion data will be compared and analysed in 56 patients using paired t tests.

 
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