NCT00961532

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 28, 2014

Completed
Last Updated

August 28, 2014

Status Verified

July 1, 2014

Enrollment Period

3 years

First QC Date

August 17, 2009

Results QC Date

July 16, 2014

Last Update Submit

August 11, 2014

Conditions

Intracerebral Hemorrhage

Keywords

intracerebral hemorrhageplatelets

Outcome Measures

Primary Outcomes (1)

  • 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.

    60 minutes after treatment start

Secondary Outcomes (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%)

    within 6 hours of study treatment

Study Arms (1)

DDAVP

EXPERIMENTAL

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

Drug: DDAVP injection (desmopressin acetate)

Interventions

DDAVP injection (desmopressin acetate)DRUG

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

DDAVP

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • 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.

    PMID: 25005444RESULT

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Results Point of Contact

Title
Andrew M Naidech
Organization
Northwestern Medicine
a-naidech@northwestern.edu
312-503-3335

Study Officials

  • Andrew M Naidech, MD MSPH

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 19, 2009

Study Start

December 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 28, 2014

Results First Posted

August 28, 2014

Record last verified: 2014-07

Locations

US(1)