IRCT201111288240N1已完成3 期
The effect of intravenous albumin in mortality and morbidity of intracranial hemorrhage; a randomized clinical trial
JondiShapur Ahvaz university of Medical Sciences0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
- 年龄范围
- 18 years 至 83 years（—）
- 性别
- All
入选标准
- •Inclusion Criteria: 1.Primary supratentorial ICH; 2.< 24 hours from symptom onset; 3.Age >18.
排除标准
- •1.ICH volume < 7 cc; 2.Glasgow Coma Scale < 8; 3.Surgical evacuation anticipated; 4.Pregnancy; 5. Breastfeeding; 6.Hemodynamic instability (SBP < 100 mmHg, > 200 mmHg); 7.Current participation in another experimental treatment protocol; 8.Renal impairment with GFR < 30 or Creatinine > 2.0; 9.History of or known allergy to albumin; 10. History of or known severe allergy to rubber latex; 11.Episode/exacerbation of congestive heart failure (CHF) from any cause in the last 6 months. (An episode of congestive heart failure is any heart failure that required a change in medication, diet or hospitalization); 12.Acute myocardial infarction in the last 6 months; 13.Elevated serum troponin level on admission > 0.1 mcg/L; 14.Known valvular heart disease with CHF in the last 6 months; 15.Known (or in the investigator's judgment) existence of severe aortic stenosis or mitral stenosis; 16.Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months; 17.Suspicion of aortic dissection on admission; 18.Acute arrhythmia (including any tachy- or bradycardia) with hemodynamic instability on admission (systolic blood pressure < 100 mmHg); 19.Findings on physical examination of any of the following: (1) jugular venous distention (JVP > 4 cm above the sternal angle), (2) 3rd heart sound, (3) resting tachycardia (heart rate > 100/min) attributable to congestive heart failure, (4) abnormal hepatojugular reflux, (5) lower extremity pitting edema attributable to congestive heart failure or without apparent cause, (6) bilateral rales, and/or (7) if a chest x-ray is performed, definite evidence of pulmonary edema, bilateral pleural effusion, or pulmonary vascular redistribution; 20.Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy; 21.Prosthetic heart valves; 22.Documented left ventricular ejection fraction < 35%.
研究者
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