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

Primary Purpose

Intracerebral Hemorrhage

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DDAVP injection (desmopressin acetate)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring intracerebral hemorrhage, platelets

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DDAVP

Arm Description

DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes

Outcomes

Primary Outcome Measures

Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment
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%)
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.

Full Information

First Posted
August 17, 2009
Last Updated
August 11, 2014
Sponsor
Northwestern University
Collaborators
Northwestern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00961532
Brief Title
Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept
Acronym
IMPACT
Official Title
Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Northwestern Memorial Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
Keywords
intracerebral hemorrhage, platelets

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DDAVP
Arm Type
Experimental
Arm Description
DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes
Intervention Type
Drug
Intervention Name(s)
DDAVP injection (desmopressin acetate)
Intervention Description
0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes
Primary Outcome Measure Information:
Title
Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment
Description
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.
Time Frame
60 minutes after treatment start
Secondary Outcome Measure Information:
Title
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%)
Description
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.
Time Frame
within 6 hours of study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew M Naidech, MD MSPH
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25005444
Citation
Naidech AM, Maas MB, Levasseur-Franklin KE, Liotta EM, Guth JC, Berman M, Rosenow JM, Lindholm PF, Bendok BR, Prabhakaran S, Bernstein RA, Kwaan HC. Desmopressin improves platelet activity in acute intracerebral hemorrhage. Stroke. 2014 Aug;45(8):2451-3. doi: 10.1161/STROKEAHA.114.006061. Epub 2014 Jul 8.
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Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept

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