| 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
|
|
|
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
|
|
|
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
|
|
|
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. |