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

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

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

Conditions
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Intracerebral Hemorrhage

Intervention / Treatment
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* Drug: DDAVP injection (desmopressin acetate)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DDAVP<br>DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes | Drug: DDAVP injection (desmopressin acetate)<br>* 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within 6 hours of study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracerebral hemorrhage, platelets