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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
Intervention / Comparator Agent
|
|
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.
|