A Phase 2 interventional study of DDAVP injection (desmopressin acetate) in Intracerebral Hemorrhage, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-08-28.
Sponsored by Northwestern University · Phase 2, Interventional, and Treatment
The investigators intend to show that DDAVP improves platelet activity from baseline to 60 minutes after treatment start.
476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.
This study's enrollment of 14 is below the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes
Drug: DDAVP injection (desmopressin acetate)
0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes
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
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
| Milestone | DDAVP |
|---|---|
| Started | 14 |
| Completed | 14 |
| Not completed | 0 |
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.
| seconds | DDAVP |
|---|---|
| Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment | 68 ± 24.1 |
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.
| participants | DDAVP |
|---|---|
| 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 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DDAVP | — | 2/14 (14.3%) | 0/14 (0%) |
| Event | DDAVP |
|---|---|
| HypotensionCardiac disorders | 1/14 |
| FeverInfections and infestations | 1/14 |
| Age, Continuous(years) | DDAVP |
|---|---|
| Mean | 66.8 ± 14.6 |
| Sex: Female, Male(Participants) | DDAVP |
|---|---|
| Female | 6 |
| Male | 8 |
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Northwestern University