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

This study has been completed.
Sponsor:
Collaborator:
Northwestern Memorial Hospital
Information provided by (Responsible Party):
Andrew Naidech, Northwestern University
ClinicalTrials.gov Identifier:
NCT00961532
First received: August 17, 2009
Last updated: August 11, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Intracerebral Hemorrhage
Drug: DDAVP injection (desmopressin acetate)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment [ Time Frame: 60 minutes after treatment start ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 14
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00961532

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Northwestern Memorial Hospital
Investigators
Principal Investigator: Andrew M Naidech, MD MSPH Northwestern University
  More Information

Publications:
Responsible Party: Andrew Naidech, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00961532     History of Changes
Other Study ID Numbers: STU8168
Study First Received: August 17, 2009
Results First Received: July 16, 2014
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
intracerebral hemorrhage
platelets

Additional relevant MeSH terms:
Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014