Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept
Information source: Northwestern University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intracerebral Hemorrhage
Intervention: DDAVP injection (desmopressin acetate) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Northwestern University Official(s) and/or principal investigator(s):
Andrew M Naidech, MD MSPH, Principal Investigator, Affiliation: Northwestern University
Overall contact:
Andrew M Naidech, MD MSPH, Phone: 312-503-3593, Email: a-naidech@northwestern.edu
Summary
The investigators intend to show that DDAVP improves platelet activity from baseline to 60
minutes after treatment start.
Clinical Details
Official title: Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in platelet activity, measured in seconds on PFA-EPI assay, from pre to post-treatment
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%)
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Andrew M Naidech, MD MSPH, Phone: 312-503-3593, Email: a-naidech@northwestern.edu
Northwestern Memorial Hospital, Chicago, Illinois 60611, United States; Recruiting
Andrew M Naidech, MD MSPH, Phone: 312-503-3592, Email: a-naidech@northwestern.edu
Andrew M Naidech, MD MSPH, Principal Investigator
Additional Information
Starting date: December 2010
Last updated: March 18, 2012
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