The Effect of Intraoperative Low Dose Adrenaline on Bleeding in Total Hip Arthroplasty - a Randomized Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 3
- 主要终点
- Intraoperative blood loss
研究概览
简要总结
The purpose of this study is to evaluate the effect of intraoperative administration of low-dose adrenaline on intraoperative blood loss in patients undergoing hip surgery.
详细描述
Hip arthroplasty is associated with bleeding, anemia and the need for allogeneic transfusion. Administration of low-dose adrenaline activates the coagulation system and may decrease intraoperative and immediate postoperative bleeding. Thus, the aim of this study is to evaluation whether intraoperative IV-administration of low-dose adrenaline reduces bleeding in elective total hip arthroplasty.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age > 18 years.
- •Scheduled for primary unilateral hip arthroplasty
- •Able to give consent
排除标准
- •Allergy towards adrenaline
- •Current treatment with: ADP receptor inhibitors or Vitamin K antagonists (within 5 days), Factor Xa inhibitors or Thrombin inhibitors (within 1 day), heparin (excluding low molecular weight heparin for perioperative thromboprophylaxis).
- •Current treatment with tricyclic antidepressants
- •Use of MAO inhibitors (within previous 14 days) or COMT inhibitors (within 2 days).
- •Acute coronary syndrome / myocardial infarction within the previous 6 months.
- •not willing to accept blood transfusion
- •Participation in other clinical trial within previous 30 days
- •Women of childbearing age (without menopause for at least 12 months)
- •Pheochromocytoma
- •Low serum K+ (< 3.0 mmol/L)
- •Thyrotoxicosis
- •Digoxin intoxication
- •Alcohol og drug abuse (investigators judgement)
研究组 & 干预措施
Adrenaline
Intraoperative low-dose adrenaline infusion
干预措施: Adrenaline (Drug)
Placebo
Placebo: Isotonic Saline
干预措施: Placebo (Drug)
结局指标
主要结局
Intraoperative blood loss
时间窗: End of surgery (last suture)
Intraoperative blood loss as estimated from surgical drain and sponges.
次要结局
- Calculated blood loss(24 hours after end of surgery.)
研究者
Oeivind Jans
M.D, Research Fellow
Rigshospitalet, Denmark