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

August 11, 2014 updated by: Andrew Naidech, Northwestern University
The investigators intend to show that DDAVP improves platelet activity from baseline to 60 minutes after treatment start.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 minutes after treatment start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 6 hours of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Northwestern Memorial Hospital

Investigators

  • Principal Investigator: Andrew M Naidech, MD MSPH, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 17, 2009

First Submitted That Met QC Criteria

August 18, 2009

First Posted (Estimate)

August 19, 2009

Study Record Updates

Last Update Posted (Estimate)

August 28, 2014

Last Update Submitted That Met QC Criteria

August 11, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU8168

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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