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Phase 2 Completed N=14 Treatment

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

Source: ClinicalTrials.gov NCT00961532 ↗
Enrolled (actual)
14
Serious AEs
14.3%
Results posted
Aug 2014
Primary outcomePrimary: Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment — 68 seconds — p=0.014

Summary

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

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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