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

Phase 2

Completed

• Conditions: Intracerebral Hemorrhage
• Interventions: Drug: DDAVP injection (desmopressin acetate)

• Registration Number: NCT00961532
• Lead Sponsor: Northwestern University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-17
• Study First Submitted QC: 2009-08-18
• Study First Posted: 2009-08-19
• Study Start: 2010-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-07
• Results First Submitted: 2014-07-16
• Results First Submitted QC: 2014-08-11
• Last Update Submitted: 2014-08-11
• Results First Posted: 2014-08-28
• Last Update Posted: 2014-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DDAVP	DDAVP injection (desmopressin acetate)	DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes

Primary Outcome Measures

Name	Time	Method
Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States