Quantification of Postoperative Coagulation Following Administration of Indomethacin to Expedite Fast-tracking of Cardiac Surgical Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- amount of blood lost via chest drains during and following cardiac bypass surgery
研究概览
简要总结
Following signed informed consent, patients scheduled for elective cardiac surgery were randomly assigned to one of 3 groups to be given acetaminophen, Indomethacin or a combination of both immediately following induction and then at 6, 12, 18 & 24 hours following surgery. Our primary outcome measure was the amount of blood drained from the mediastinal tubes and chest drains. Secondary outcome measures included conventional blood coagulation indices as well as other measures of clotting as indicated by thromboelastography (TEG). Other secondary outcome measures included consumption of morphine equivalents and pain scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled to undergo either elective coronary artery bypass or single valve replacement
- •normal platelet count
- •normal prothrombin time
- •normal partial thromboplastin time
- •normal serum creatinine
排除标准
- •sensitivity to study drugs
- •history of bleeding diathesis
- •renal dysfunction
- •active peptic ulcer
研究组 & 干预措施
Acetaminophen
Participants received a loading dose of acetaminophen (2600 mg) at induction followed by 1300 mg at 6, 12, 18 and 24 hours following cardiac bypass surgery.
干预措施: Acetaminophen (Drug)
Indomethacin
Participants were given 100 mg of indomethacin at induction and then 50 mg at 6, 12, 18 and 24 hours following cardiac bypass surgery.
干预措施: Indomethacin (Drug)
Combination
Participants were given a loading dose of 1300 mg of acetaminophen and 50 mg of Indomethacin followed by 650mg of acetaminophen and 25 mg of indomethacin at 6, 12, 18 and 24 hours following cardiac bypass surgery.
干预措施: Acetaminophen & Indomethacin (Drug)
结局指标
主要结局
amount of blood lost via chest drains during and following cardiac bypass surgery
时间窗: during surgery and then until chest drains removed (< 24 hours)
次要结局
- blood clotting indices (i.e., conventional and using thromboelastography)(perioperative period until 24 hours post-operative)
- Morphine equivalents required to provide effective analgesia(perioperative period until 24 hours post-operative)
- pain scores(perioperative period until 24 hours post-operative)