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CTRI Number  CTRI/2024/05/066626 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 30/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Is Hemocue accurate for hemoglobin measurement? 
Scientific Title of Study   Hemocue as a guide for intraoperative blood transfusion 
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 Faizan 
Designation  Postgraduate student 
Affiliation  University College of Medical Sciences and GTB Hospital 
Address  Room No 631 B Department of Anaesthesiology UCMS and GTB Hospital Dilshad Garden Delhi

East
DELHI
110095
India 
Phone  7982354381  
Fax    
Email  faizanqayyum2505@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rashmi Salhotra 
Designation  Professor 
Affiliation  University College of Medical Sciences, Delhi 
Address  Room No 631 B Department of Anaesthesiology UCMS and GTB Hospital Dilshad Garden Delhi

East
DELHI
110095
India 
Phone  9911317334  
Fax    
Email  rashmichabra@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rashmi Salhotra 
Designation  Professor 
Affiliation  University College of Medical Sciences, Delhi 
Address  Room No 631 B Department of Anaesthesiology UCMS and GTB Hospital Dilshad Garden Delhi

East
DELHI
110095
India 
Phone  9911317334  
Fax    
Email  rashmichabra@yahoo.com  
 
Source of Monetary or Material Support  
University College of Medical Sciences Dilshad Garden Delhi India 110095 
 
Primary Sponsor  
Name  University College of Medical Sciences 
Address  Dilshad Garden Delhi 
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 Faizan  University College of Medical Science  Department of Anaesthesiology, Critical Care and Pain Medicine University College of Medical Sciences (University of Delhi) and GTB Hospital East DELHI
East
DELHI 
7982354381

faizanqayyum2505@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE - HUMAN RESEARCH (IEC-HR)  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 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  ASA I or II 
 
ExclusionCriteria 
Details  Baseline Hb less than 8 gm per dl
INR more than 1.3
Platelet count less than 1 lac per cumm 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean difference, upper and lower limit of agreement between the Hemocue hemoglobin and visual hemoglobin  Once, at the time when maximum allowable blood loss is achieved 
 
Secondary Outcome  
Outcome  TimePoints 
Mean difference, upper and lower limit of agreement between the Lab hemoglobin and visual hemoglobin  Once, at the time when maximum allowable blood loss is achieved 
Mean difference, upper and lower limit of agreement between the Hemocue hemoglobin and lab hemoglobin  Once, at the time when maximum allowable blood loss is achieved 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
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)   13/05/2024 
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="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Background and purpose: Surgical procedures are associated with blood loss. Quantification of the lost blood during surgery helps guide appropriate replacement to maintain homeostasis. The decision to transfuse blood intraoperatively is very commonly based on visual estimates which may be inaccurate or laboratory hemoglobin levels which have a longer waiting time for results. Hemoglobin estimation of lost blood using HemoCue has been done but, we could not locate any study which has measured patient’s hemoglobin level with HemoCue and correlated it with the target hemoglobin when visual estimated surgical blood loss is equal to maximum allowable blood loss [MABL].

Aim: To determine the ability of HemoCue as a guide for intraoperative blood transfusion

Objectives: To determine the mean difference, upper and lower limits of agreement in following at the time of MABL: 

Primary objective:

1. Estimated blood loss with HemoCue hemoglobin and average visual blood loss.

Secondary objectives:

1. Estimated blood loss with laboratory hemoglobin and average visual blood loss.
2. Estimated blood loss with HemoCue hemoglobin and laboratory hemoglobin.
3. Upper and lower limits of agreement with hemoglobin measured with HemoCue and laboratory analyser.

Methods: This Prospective cross-sectional study will be conducted after obtaining approval from Institutional Ethics Committee-Human Research between April 2024 to August 2025. Consenting patients who fulfil the inclusion criteria will be explained about the study procedure and 3 ml of patient’s venous blood samples will be collected in an EDTA vial and transported to the laboratory for Hb assessment (Hblab1). On the day of surgery, anaesthesia will be induced. Careful intraoperative fluid therapy will be given till the blood loss is below maximum allowable blood loss. Two experienced anaesthesiologists (one consultant and one Senior Resident) will independently assess the visual blood loss (VBL) during the procedure. An average of the two values will be taken as the average visual blood loss (VBLAV). Once the VBLAV ≥MABL, another 3 ml venous blood sample will be withdrawn. One drop will be used for hemoglobin assessment with HemoCue (HbH) and the rest of it will be transported in EDTA vial for Hb estimation in the laboratory (HbLab2). If by the end of surgical procedure, MABL is not reached, the patient will be excluded from the study. 

Sample size: There are no studies which have estimated blood loss by measuring HemoCue hemoglobin of patient’s blood in the intraoperative period. However, in the study by Zajak et al. HemoCue was used to estimate blood loss by measuring Hemoglobin of suction blood. Assuming that all the lost blood was collected in this study in the suction bottle and thus, the estimated blood loss in suction blood is equal to actual total blood loss, we have calculated the sample size from this study. Considering the mean blood loss of 251 [109-411] ml with the HemoCue and visually estimated blood loss of 300 [200-500] ml as per the study by Zajak et al, to estimate this difference in blood loss at α=5% and power=80%, a sample of 50 patients is required. To account for loss to follow up in 25% patients (due to non-achieving of MABL by the end of surgery), a sample of 63 patients is required. 

 Statistical analysis: Data will be entered in a spreadsheet. Analysis will be done in SPSS version 20.0. Paired t-test will be used to compare the blood loss by different methods as these are being applied in the same patient. Bland Altmann analysis to calculate the mean difference between two methods and the upper and lower limits of agreement will be applied. A p-value <0.05 will be taken as significant.



 
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