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Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00961532
Recruitment Status : Completed
First Posted : August 19, 2009
Results First Posted : August 28, 2014
Last Update Posted : August 28, 2014
Northwestern Memorial Hospital
Information provided by (Responsible Party):
Andrew Naidech, Northwestern University

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

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Drug: DDAVP injection (desmopressin acetate) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept
Study Start Date : December 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: DDAVP
DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes
Drug: DDAVP injection (desmopressin acetate)
0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00961532

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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Northwestern Memorial Hospital
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Principal Investigator: Andrew M Naidech, MD MSPH Northwestern University
Publications of Results:
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Responsible Party: Andrew Naidech, Associate Professor, Northwestern University Identifier: NCT00961532    
Other Study ID Numbers: STU8168
First Posted: August 19, 2009    Key Record Dates
Results First Posted: August 28, 2014
Last Update Posted: August 28, 2014
Last Verified: July 2014
Keywords provided by Andrew Naidech, Northwestern University:
intracerebral hemorrhage
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Deamino Arginine Vasopressin
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs