Clinical Trial: Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept

Brief Summary: The investigators intend to show that DDAVP improves platelet activity from baseline to 60 minutes after treatment start.

Detailed Summary:
Sponsor: Northwestern University

Current Primary Outcome: Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment [ Time Frame: 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.


Original Primary Outcome: Platelet activity, measured in aspirin reaction units [ Time Frame: 30-60 minutes after treatment ]

Current Secondary Outcome: 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%) [ Time Frame: within 6 hours of study treatment ]

We prospectively defined acute adverse events as: 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%). The two patients reported were the only two that sustained any of the prospectively defined adverse events.


Original Secondary Outcome: 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%) [ Time Frame: within 4 hours of study treatment ]

Information By: Northwestern University

Dates:
Date Received: August 17, 2009
Date Started: December 2010
Date Completion:
Last Updated: August 11, 2014
Last Verified: July 2014