NCT05426031已完成4 期
Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass: A Blinded Randomized Control Trial Comparing Two Strategies
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Activated Clotting Time
研究概览
简要总结
The purpose of this study is to compare two different dosing strategies of a drug named protamine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients greater than or equal to 18 years of age undergoing elective cardiac surgery with cardiopulmonary bypass.
- •Patients must that have a calculated protamine dose greater than 250 mg based on standard 1:1 initial heparin to protamine dosing calculation.
排除标准
- •Patients who are under 18 years of age or pregnant.
- •Patients undergoing emergency surgery (ASA class E).
- •Patients with known coagulation disorders.
- •Patients requiring circulatory arrest or deep hypothermia.
- •Patients who have not had the appropriate interruption in coumadin, direct oral anticoagulants or non-aspirin antiplatelet agents.
- •Patients on pre-operative intravenous unfractionated heparin infusions.
- •Patients ineligible for heparin administration due to known adverse reactions including allergy or heparin induced thrombocytopenia or known heparin resistance.
- •Patients who are unable to provide informed consent in the form of a signature.
- •History of adverse reaction to protamine.
- •Have any condition that, in the opinion of the investigator, will compromise the well-being of the patient or the study, or prevent the patient from meeting or performing study requirements.
研究组 & 干预措施
Fixed Dose Protamine group
Experimental
Participants in the group will receive a one time dose of 250 mg Protamine to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery.
干预措施: Protamine fixed dose (Drug)
Ratio Dose Protamine Group
Active Comparator
Participants in the group will receive a ratio dose of Protamine in a 1mg per 100 units of heparin ratio to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery.
干预措施: Protamine ratio dose (Drug)
结局指标
主要结局
Activated Clotting Time
时间窗: up to 4 hours (after cardiopulmonary bypass surgery)
Activated clotting times will be measured using standard coagulation monitor
次要结局
- Additional Protamine Dosing(Up to 4 hours)
- Chest Tube Output(Up to 24 hours)
- Count of Participants Receiving Red Blood Cell Transfusion(Up to 4 hours)
研究者
Michael Fabbro
Associate Professor
University of Miami
研究点 (2)
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