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CTRI Number  CTRI/2019/04/018756 [Registered on: 24/04/2019] Trial Registered Prospectively
Last Modified On: 18/04/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Risk factors for blood requirement in coronary artery bypass surgery 
Scientific Title of Study   Predictors of packed red blood transfusion in patients undergoing off pump coronary artery bypass graft surgery  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijaya Kumara 
Designation  Assistant Professor 
Affiliation  Kasturba Medical Collage Manipal 
Address  Department of Anaesthesia KMC Manipal Udupi
244 quarter KMC campus Manipal
Udupi
KARNATAKA
576104
India 
Phone  8970213332  
Fax    
Email  vijaysd84@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijaya Kumara 
Designation  Assistant Professor 
Affiliation  Kasturba Medical Collage Manipal 
Address  Department of Anaesthesia KMC Manipal Udupi
244 quarter KMC campus Manipal
Udupi
KARNATAKA
576104
India 
Phone  8970213332  
Fax    
Email  vijaysd84@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vijaya Kumara 
Designation  Assistant Professor 
Affiliation  Kasturba Medical Collage Manipal 
Address  Department of Anaesthesia KMC Manipal Udupi
244 quarter KMC campus Manipal
Udupi
KARNATAKA
576104
India 
Phone  8970213332  
Fax    
Email  vijaysd84@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical Collage and Hospital Manipal Udupi Karnataka-576104 
 
Primary Sponsor  
Name  Kasturba Medical Collage and Hospital 
Address  Manipal Udupi 
Type of Sponsor  Research institution and hospital 
 
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 Vijayakumara  Kasturba Medical Collage and Hospital  Department of anesthesiology Kasturba Medical Collage Manipal
Udupi
KARNATAKA 
8970213332

vijaysd84@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical Collage and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Off pump CABG surgeries
2. Elective CABG
 
 
ExclusionCriteria 
Details  1. Emergency CABG
2. Patients undergoing combined surgeries like
CABG + AVR or CABG + MVR
3. On pump CABG
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Packed red blood cell transfusions intraoperatively.
2. Reoperation rate for bleeding or cardiac tamponade 
Six days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Total chest tube drain
2. Total number of blood transfusions 
Six days 
 
Target Sample Size   Total Sample Size="142"
Sample Size from India="142" 
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   Phase 4 
Date of First Enrollment (India)   30/04/2019 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Hospital Research Ethics Committee approval will be obtained. Data of all patients who had undergone elective off pump CABG will be obtained from hospital record section. Patients who had undergone emergency CABG surgeries, combined surgeries like CABG with MVR or CABG with AVR and on pump CABG are excluded from study. Preoperative investigations like CBC, renal functions, coagulation profile etc. will be collected from hospital laboratory reports.

Pre-operative parameters analyzed will include age, sex, body surface area (BSA), left main coronary artery stenosis >50%, antiplatelet medications within 7 days before operation, pre-operative heparin therapy, recent history of myocardial infarction (within 6 months), ejection fraction , previous cardiac surgery, chronic renal failure, cerebrovascular disease, antifibrinolytic drugs and last preoperative Hct. Intraoperative data consisted of number of distal anastomoses performed, use of internal mammary arteries (IMA), and lowest intraoperative Hct documented.

 

The primary endpoints of interest will be packed red blood cell transfusions, reoperation rate for bleeding or cardiac tamponade and total postoperative chest tube drainage. Only intraoperative and postoperative homologous packed RBC transfusions will be recorded.

 

 

 
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