FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/066822 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 04/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational 
Study Design  Other 
Public Title of Study   To do Hemoglobin of patient before and after giving blood during surgery then decide it was actually neccessary to give blood or not 
Scientific Title of Study   Assessment of intraoperative blood transfusion practice during elective surgery in tertiary care teaching hospital 
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 Krupa marvaniya 
Designation  2nd year anesthesia resident 
Affiliation  Government medical college- surat 
Address  2nd Floor, old college building ,Department of Anesthesia,Government medical college Surat,near majura gate,

Surat
GUJARAT
395001
India 
Phone  7202078568  
Fax    
Email  km07marvaniya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neeta kavishvar 
Designation  Professor and head department of Anaesthesia 
Affiliation  Government medical college surat 
Address  2nd floor,old college building,Department of Anesthesia ,government medical college -surat near majura gate

Surat
GUJARAT
395001
India 
Phone  9825615264  
Fax    
Email  neetakavishvar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neeta kavishvar 
Designation  Professor and head department of Anaesthesia 
Affiliation  Government medical college surat 
Address  2nd floor,old college building,Department of Anesthesia ,government medical college -surat near majura gate

Surat
GUJARAT
395001
India 
Phone  9825615264  
Fax    
Email  neetakavishvar@gmail.com  
 
Source of Monetary or Material Support  
Government Medical college and new civil hospital surat 
 
Primary Sponsor  
Name  Government Medical college and new civil hospital,surat 
Address  New civil hospital ,near Majura gate,Surat 
Type of Sponsor  Government 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 Krupa marvaniya   New civil hospital   1st and 2nd floor OT complex,Surgery ,Orthopedic,gynaecology operation theatre and post operation recovery room. Pin.395001
Surat
GUJARAT 		 7202078568

km07marvaniya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Research ethics’s committee of GMC surat  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  99.00 Year(s)
Gender  Both 
Details  Patients of either sex above 18 years posted for any planned major surgery who is likely to receive blood transfusion perioperatively and ready to give consent for measuring post operatively Hb 
 
ExclusionCriteria 
Details  1.Patients posted for emergency surgery 2.Peadiatric patients. 3.Pregant patients 4.Patients receiving massive blood transfusion 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Indications for transfusion, 2.Demographic profile of the patient receiving blood transfusion, 3.Type of surgery, 4.duration of surgery, 5. Comorbidity and appropriateness of blood transfusion   At time of operation completion  
 
Secondary Outcome  
Outcome  TimePoints 
1.formation of rational blood transfusion practice for anaesthesia department. 2.Documentation of various problems faced during blood transfusion.  After data collection 
 
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)   20/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/05/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
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   Blood is a scarce resource,Blood transfusion Is not without any hazards,many infectious and non infectious diseases can occurs due to blood transfusion,various societies of anaesthesiology,hematology and blood transfusion publish transfusion guidelines but there is no global uniform transfusion guidelines.It is appeared from literature reviewed that very few studies are done to assess blood transfusion practice during surgery (anaesthesia ).safer transfusion practice are slowly evolving but they may be enhanced by prospective audits in to the use of blood in surgical practice.So in this study we are doing pre transfusion and post transfusion Hb estimation by point of care method for Hb estimation and the purpose of the study is to observe the blood transfusion practice by anaesthetist in our hospital to see trigger of transfusion and appropriateness of transfusion. we will compare the data with American society of anaesthesiology task force guideline,2015. On the basis of result of study we will also form separate guideline of blood transfusions for our department.which can add some value to improve transfusion practice. 
Close