CTRI/2016/06/006988招募中4 期
Comparison of bivalirudin to heparin with protamine reversal in acyanotic children undergoing open heart surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Children aged 1-12 years of either sex with acyanotic congenital heart disease undergoing open heart surgery
排除标准
- •Emergency surgery
- •Previous cardiac surgery
- •Multiple ventricular septal defects
- •Cyanotic congenital heart disease
- •Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
- •Intracranial neoplasm, arteriovenous malformation, or aneurysm.
- •History of gastrointestinal or genitourinary bleeding in the previous 2 weeks
- •Acquired or congenital bleeding disorder
- •Patients with renal dysfunction (serum creatinine > 2 mg/dL) or undergoing renal dialysis
- •Received warfarin with INR >1.5 immediately prior to the procedure or UFH less than 1 hour prior or low molecular weight heparin < 12 hours prior to the surgery
- •Known allergy to bivalirudin or hirudin derived drugs, or known sensitivity to any component of the product.
- •Refusal to undergo blood transfusion should it become necessary.
- •Any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial or inability to comply with study requirements
研究者
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