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CTRI Number  CTRI/2017/05/008549 [Registered on: 12/05/2017] Trial Registered Retrospectively
Last Modified On: 28/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Blood transfusion practices during surgery 
Scientific Title of Study   Assessment of intraoperative blood transfusion practices during elective surgeries in a tertiary care hospital 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prerana Nirav Shah 
Designation  Professor Additional 
Affiliation  GSMC KEMH 
Address  Department of Anaesthesiology, GSMC KEMH, Parel, Mumbai, Maharashtra Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9869117027  
Fax    
Email  pps@kem.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mansi Vaidya 
Designation  Resident 
Affiliation  GSMC KEMH 
Address  Department of Anaesthesiology, GSMC KEMH, Parel, Mumbai, Maharashtra Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9819223064  
Fax    
Email  vmansi25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prerana Nirav Shah 
Designation  Professor Additional 
Affiliation  GSMC KEMH 
Address  Department of Anaesthesiology, GSMC KEMH, Parel, Mumbai, Maharashtra Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9869117027  
Fax    
Email  pps@kem.edu  
 
Source of Monetary or Material Support  
Dr Mansi Vaidya, Department of Anaesthesiology, GSMC & KEMH, Parel, Mumbai 400012 
 
Primary Sponsor  
Name  Self 
Address  Department of Anaesthesiology, GSMC KEMH, Parel, Mumbai, Maharashtra Mumbai MAHARASHTRA 400012 India 
Type of Sponsor  Other [Self] 
 
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 Prerana Nirav Shah  GSMC KEMH  Department of Anaesthesiology, GSMC KEMH, Parel, Mumbai, Maharashtra Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA 
9869117027

pps@kem.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC - II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  The anaesthesiologists (faculty and post graduate residents) in department at GSMC & KEMH who give consent for the study. Blood transfusion given intraoperatively in elective surgeries. 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  62.00 Year(s)
Gender  Both 
Details  The anaesthesiologists (faculty and post graduate residents) in department at GSMC & KEMH who give consent for the study.
Blood transfusion given intraoperatively in elective surgeries. 
 
ExclusionCriteria 
Details  Anaesthesiologists who refuse consent for the study.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To ascertain the common indications for which the anaesthesiologists start perioperative blood transfusion and the rates of intraoperative blood overtransfusion.  Postoperative 
 
Secondary Outcome  
Outcome  TimePoints 
To assess variation in the blood transfusion practices from the standard guidelines.   nil 
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/01/2017 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Introduction: Blood transfusion is often required in major surgeries. It is a scarce resource. Also, allogenic blood transfusion in associated with many potential adverse effects. They include acute and delayed hemolytic reactions, infections, fluid overload and many others. Therefore it is crucial that blood transfusion is done judiciously. A critical approach is required where blood transfuion is concerned so as to minimize the adverse effects to the patient. Studies have looked at perioperative blood transfusion practice and have identified inappropriate transfusion rates between 19 and 53% 1-5. It has been identified that audits regarding blood transfusion practices may help to identify problems in blood tranfusion practice and help to control and decrease rates of inappropriate transfusion 2-4, 6-8. Perioperative blood transfusion is defined as transfusion of RBCs (packed cells or whole blood) during or within 24 hours after surgery.  Based on ASA guidelines, a patient will be considered overtransfused if the post transfusion postoperative haemoglobin concentration is more than 10g%. This cut-off is based on the ASA guidelies , which suggest that patients with Hb more than 10g% almost never need transfusions9.   This study is a prospective observational study to observe the existing perioperative blood transfusion practices in our tertiary care institute.

Aims and Objectives: The aim of this study is to evaluate the existing  perioperative blood transfusion practices and the appropriateness of transfusion.

Primary Objective: To ascertain the common indications for which the anaesthesiologists start perioperative blood transfusion and the rates of intraoperative blood overtransfusion.

Secondary Objective: To assess variation in the blood transfusion practices from the standard guidelines.

Methodology: After Ethics Committe approval and informed consent  from anaesthesiologists of the department at GSMC & KEMH, the prospective study would be done over a period of 6 months. Operation theatre anesthesiologists will be given a form to complete for each patient given blood transfusion during elective surgery. The form will ask indications for which they deemed fit to transfuse blood intraoperatively- whether the triggering factor was pallor, hypovolemia, hemodynamic instability, blood loss , haemoglobin level, surgeon’s request or any other reasons.It would include details of the intraoperative blood loss and fluid therapy given. During surgery, two standard size gauze pieces are used.

 Each fully soaked small gauze piece=20 ml

 Each fully soaked large gauze piece=100 ml

Intraoperative blood loss will be calculated by the gauze pieces used during surgery and by measuring the volume of blood in the suction bottle after deduction of any washing fluid given during the surgery.

 

The immediate post operative haemoglobin of the patient will be documented. From the information obtained, the common indications for blood transfusion in our hospital will be assessed. Based on the level of haemoglobin post operatively, the rate of appropriate blood transfusions will be evaluated. The variation in blood transfusion practices from the standard guidelines will be assessed. The standard indications for blood transfusion include:

1.      Blood loss greater than 20% of blood volume when more than 100ml.

2.      Haemoglobin level less than 8 g/dl

3.      Haemoglobin level less than 10g/dl with major disease (e.g. emphysema, ischemic heart disease)

4.      Hemoglobin level less than 10g/dl with autologous blood.

5.      Haemoglobin level less than 12g/dl and ventilator dependant. 9

The protocol and Case record form were discussed and approved by the professors of the department.

Study Design: It is a prospective observational study.

Inclusion Criteria: The anaesthesiologists (faculty and post graduate residents) in department at GSMC & KEMH who give consent for the study.

Blood transfusion given intraoperatively in elective surgeries.

Exclusion Criteria: Anaesthesiologists who refuse consent for the study.

Statistical Analysis: Since this is an observational study, descriptive statistics will be used for the study population and will be expressed as numbers (%) or mean. Chi square test will be used for comparing categorical variables and P value of 0.05 or less considered significant.

Sample size will be 168 according to the formula:

 n=Z2 pqN*e2(N-1)+Z2pq

where p= proportion percentage of the most common variable in the population studies

            q= 100-proportion

            e= 5%

            N= Total cases

            Z=1.9   

 
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