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

Intracerebral Hemorrhage Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961532
• Other study ID #: STU8168
• Status: Completed
• Phase: Phase 2
• First received: August 17, 2009
• Last updated: August 11, 2014
• Start date: December 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Drug:
• DDAVP injection (desmopressin acetate)
0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Northwestern Memorial Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes