Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment
研究概览
简要总结
The investigators intend to show that DDAVP improves platelet activity from baseline to 60 minutes after treatment start.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spontaneous intracerebral hemorrhage as documented by head CT scan
- •Documented regular aspirin use or VerifyNow-ASA result of ≤ 550 aspirin reaction units (ARU), indicating anti-platelet medication
排除标准
- •International normalized ratio (INR) of ≥ 1.7 from coagulopathy or warfarin use
- •History of von Willebrand disease
- •Pregnancy
- •Known hypersensitivity to DDAVP or desmopressin
- •Active cardiovascular disease or unstable angina
- •Hyponatremia or history of hyponatremia
- •Current or historical deep venous thrombosis or pulmonary embolism
研究组 & 干预措施
DDAVP
DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes
干预措施: DDAVP injection (desmopressin acetate) (Drug)
结局指标
主要结局
Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment
时间窗: 60 minutes after treatment start
The Platelet Function Analyzer (PFA) is a commercially available point-of-care assay that measures the time to closure of an aperature. Longer time to closure indicates less platelet activity. EPI denotes epinephrine (as opposed to adenosine diphosphate) as the stimulant to platelet aggregation. In our laboratory, a time to closure of at least 172 seconds in consistent with an aspirin effect.
次要结局
- Adverse Events : New Fever >=100.4F, Respiratory Distress or Pulmonary Edema on Chest Radiography, Rash, Hypotension (Systolic BP < 100 mm Hg or New Vasopressor Use or Increase in Vasopressor Dose by >25%)(within 6 hours of study treatment)
研究者
Andrew Naidech
Associate Professor
Northwestern University