Phase 2
N=14
Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept
Intracerebral Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT00961532 ↗Enrolled (actual)
14
Serious AEs
14.3%
Results posted
Aug 2014
Primary outcome: Primary: Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment — 68 seconds — p=0.014
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DDAVP injection (desmopressin acetate) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment |
68 | 0.014 sig |
| 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%) |
2 | — |
Summary
The investigators intend to show that DDAVP improves platelet activity from baseline to 60 minutes after treatment start.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00961532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.