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

Northwestern University14 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intracerebral Hemorrhage

Interventions

DDAVP injection (desmopressin acetate)DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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 (1)

Northwestern Memorial Hospital

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 60 minutes after treatment start

Secondary Outcomes

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.

Time frame: within 6 hours of study treatment

Data from ClinicalTrials.gov

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