Trial Outcomes & Findings for Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept (NCT NCT00961532)

NCT ID: NCT00961532

Last Updated: 2014-08-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: 60 minutes after treatment start
• Results posted on: 2014-08-28

Participant Flow

Participant milestones

Measure	DDAVP DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	DDAVP n=14 Participants DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes
Age, Continuous	66.8 years STANDARD_DEVIATION 14.6 • n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants

PRIMARY outcome

Timeframe: 60 minutes after treatment start

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.

Outcome measures

Measure	DDAVP n=14 Participants DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes 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	68 seconds Standard Error 24.1

SECONDARY outcome

Timeframe: within 6 hours of study treatment

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.

Outcome measures

Measure	DDAVP n=14 Participants DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes
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 participants

Adverse Events

DDAVP

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	DDAVP n=14 participants at risk DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes
Cardiac disorders Hypotension	7.1% 1/14
Infections and infestations Fever	7.1% 1/14

Other adverse events

Adverse event data not reported

Additional Information

Andrew M Naidech

Northwestern Medicine

Phone: 312-503-3335

Email: a-naidech@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place