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

Information source: Northwestern University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Intracerebral Hemorrhage

Intervention: DDAVP injection (desmopressin acetate) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Northwestern University

Official(s) and/or principal investigator(s):
Andrew M Naidech, MD MSPH, Principal Investigator, Affiliation: Northwestern University

Summary

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

Clinical Details

Official title: Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment

Secondary outcome: 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%)

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

Northwestern Memorial Hospital, Chicago, Illinois 60611, United States
Additional Information

Starting date: December 2010
Last updated: August 11, 2014

Page last updated: August 23, 2015

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