| CTRI Number |
CTRI/2024/10/075225 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing blood clotting factors in patients receiving or not receiving remaining pump blood after heart valve surgery |
|
Scientific Title of Study
|
Comparison of Hemostatic parameters in patients with and without transfusion of Residual pump blood following Protamine administration in Valve replacement surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nireeksha |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Perfusion Technology, Manipal College of Professions, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9606351249 |
| Fax |
|
| Email |
nireeksha019@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Guruprasad Rai |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Room No.32, 3rd floor OPD building, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886730726 |
| Fax |
|
| Email |
drgururai13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sainath |
| Designation |
Assistant Professor and Program Coordinator |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room No.413, 4th floor, Perfusion Technology program, Manipal College of Health Professions, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9060172211 |
| Fax |
|
| Email |
sai.sainath96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiovascular and Thoracic Surgery, Room No.32, Third floor, OPD building, Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Room No.32, Third floor, OPD building, Kasturba Hospital, Manipal |
| 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 |
| Nireeksha |
Kasturba Hospital |
Department of Cardiovascular and Thoracic surgery, Room No.32, Third floor, OPD building, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9606351249
nireeksha019@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I061||Rheumatic aortic insufficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
• Elective adult cardiac surgeries undergoing cardiopulmonary bypass in Isolated Single Valve Replacement Surgeries
• Group A - Male patients having Hb less than 10g/dL and female patients having Hb less than 9g/dL are considered
• Group B - Male patients having Hb more than 10g/dL and female patients having Hb more than 9g/dL are considered
|
|
| ExclusionCriteria |
| Details |
• Emergency cardiac surgeries
• Redo Surgeries
• Patients below 18 years and patients above 70 years
• Patients on oral anticoagulation
• Anemic Patients
• Pre-existing coagulopathy disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome measures is to assess the post operative chest tube drains, need of blood transfusion and re-exploration. |
1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/10/2024 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study is done to compare the haemostatic parameters in patients with or without transfusing the residual pump blood following protamine administration in valve replacement surgeries and it is performed to determine the safety and efficacy of transfusing unprocessed residual pump blood post protamine administration in valve replacement surgeries. This proposed study can further reduce the allogeneic blood transfusion in post operative period and reduces the complication caused by it, and it would further help to clarify whether this approach poses an increased bleeding risk or can be a safe alternative to homologous blood transfusion. |