| 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
|
|
|
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
|
|
|
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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