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临床试验/CTRI/2024/08/072588
CTRI/2024/08/072588招募中不适用

Heparin Dose Response Curve for Heparin Dose Determination During Paediatric Cardiopulmonary Bypass for Cardiac Surgery: A Prospective Randomised Control Study

AIIMS NEW DELHI1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
To ascertain whether or not heparin dose administered as determined by HDR curve achieves target ACT of 480 before CPB.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
0.00 Day(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Pediatric cardiac surgical patients less than 14 years old posted for elective cardiac surgery on cardiopulmonary bypass.

排除标准

  • 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.

结局指标

主要结局

To ascertain whether or not heparin dose administered as determined by HDR curve achieves target ACT of 480 before CPB.

时间窗: Before going on bypass.

次要结局

  • To compare total dose of heparin given in both the groups.(To compare protamine dose administered in both the groups.)

研究者

发起方
AIIMS NEW DELHI
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Pavana Gokhale

AIIMS DELHI

研究点 (1)

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