| CTRI Number |
CTRI/2024/08/072588 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
HDR Curve for Heparin Dose Determination in pediatric patients undergoing cardiac surgery
|
|
Scientific Title of Study
|
Heparin Dose Response Curve for Heparin Dose Determination During Paediatric Cardiopulmonary Bypass for Cardiac Surgery: A Prospective Randomised Control Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavana Gokhale |
| Designation |
Senior Resident |
| Affiliation |
AIIMS DELHI |
| Address |
Department of Cardiac Anaesthesia and Critical Care,C.N.Centre, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9611435018 |
| Fax |
|
| Email |
gokhalepavana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Chauhan |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Dept of Cardiac Anaesthesia and Critical Care
Cardiac Neuro centre
AIIMS New Delhi
New Delhi
South
DELHI
110049
India |
| Phone |
9873729366 |
| Fax |
|
| Email |
sdeep61@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Chauhan |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Dept of Cardiac Anaesthesia and Critical Care
Cardiac Neuro centre
AIIMS New Delhi
New Delhi
South
DELHI
110049
India |
| Phone |
9873729366 |
| Fax |
|
| Email |
sdeep61@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
Ansari Nagar East, New Delhi, Delhi 110049 |
| 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 Pavana Gokhale |
AIIMS NEW DELHI |
Cardiac OT, 1st floor, CNC building, AIIMS New Delhi
New Delhi
DELHI |
9611435018
gokhalepavana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Postgraduate Research, AIIMS New Delhi |
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 |
HDR curve method for Heparin dose determination before going on CPB |
In HDR group, a dose of 2mg/kg heparin is administered intravenously after sternotomy. A timer which is available in the monitors will be started. Three minutes later, ACT will be repeated. A heparin dose-ACT response curve is then constructed. Dose of heparin required to achieve target ACT of 480 is determined from the dose response curve. The dose determined by DRC is administered intravenously. Again, after three minutes, ACT will be repeated. Whether or not the target ACT is achieved is recorded. If the target is not reached, 1.5mg/kg of heparin is repeated and ACT value determined after three minutes. |
| Comparator Agent |
Weight based method |
In Control group, conventional weight-based method is used. A baseline ACT is determined. A dose of 4mg/kg heparin is administered intravenously at the time of aortic purse string suture placement and after three minutes ACT is repeated and the value is recorded. If the target is not reached, 1.5mg/kg of heparin is repeated and ACT value determined after three minutes. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric cardiac surgical patients less than 14 years old posted for elective cardiac surgery on cardiopulmonary bypass. |
|
| ExclusionCriteria |
| Details |
Patients who refuse to participate in the study
Emergency surgery
Redo surgery
Patients with allergy to Heparin or Protamine
Renal dysfunction
Severe liver disease
CPB time more than 180 minutes
Patients on preoperative anticoagulants
Patients greater than 14 years of age
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To ascertain whether or not heparin dose administered as determined by HDR curve achieves target ACT of 480 before CPB. |
Before going on bypass. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare total dose of heparin given in both the groups.
To compare protamine dose administered in both the groups.
To compare amount of postoperative blood loss between the study groups.
|
Intraoperative and post operative |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Cardiac surgery/ Open Heart Surgery (OHS) using cardiopulmonary bypass (CPB) exposes blood to a large artificial surface, which creates a pro-coagulant state leading to thrombin generation. Intravascular catheters and cannulae cause disruption in laminar blood flow, which predisposes to clot formation. Systemic anticoagulation to prevent thrombus formation is necessary during CPB. Unfractionated heparin has been the most used anticoagulant for more than 70 years since the development of cardiopulmonary bypass (CPB).Optimum dosing of heparin is necessary because excess dose of heparin during CPB had already been identified as a major factor in excessive postoperative bleeding. Other adverse effects of heparin administration include anaphylactic and allergic reactions, thrombocytopenia, osteoporosis, skin necrosis and hypoaldosteronism. In children who undergo CPB, restoration of hemostasis following surgery with CPB is more difficult. Hemodilution, hypothermia, low flow, circulatory arrest and the age-related differences in the coagulation system, responses to heparin and protamine, hemostatic abnormalities, and polycythemia all contribute to the challenge. To dose heparin, many of the protocols used in pediatrics have been extrapolated from adults without assessing the optimal heparin dose in pediatric patients of different ages and sizes. Heparin dosing can be done by a weight-based (WB) or heparin dose ACT-curve response (HDR) method. The WB protocol calculates the dose based on the patient’s actual weight and uses an activated clotting time (ACT) test to ensure anticoagulation. The HDR method predicts the patient’s response to heparin by projecting a heparin dose–response (HDR) curve.
We have planned to conduct a prospective study of heparin dosing by heparin dose-ACT response curve (HDR method) and compare it with conventional weight-based (WB) method.
We hypothesise that heparin given by heparin dose-ACT response curve (HDR method) would provide accurate heparin dose before bypass indicated by attainment of target ACT in pediatric patients.
|