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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

Short name IMPACT

NCTNCT00961532 (opens ClinicalTrials.gov in a new tab)Other idSTU8168
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
14 participants (actual)
Sponsor
Northwestern University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Dec 2010
Primary completion
Dec 2013
Completion
Dec 2013
First posted
19 Aug 2009 (estimated)
Last update posted
28 Aug 2014 (estimated)
Conditions
Intracerebral Hemorrhage

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20102011201220132014
  1. Ph 2

    IMPACT

    NCT00961532

    Dec 2010 to Dec 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • DDAVP injection (desmopressin acetate)Drug

Arms1

  • Experimental

    DDAVP

    DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment

    Time frame · 60 minutes after treatment start

    Registry description

    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.

Secondary outcomes(1)

  1. 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%)

    Time frame · within 6 hours of study treatment

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 60 minutes after treatment start

Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment

GroupValue (seconds)Spread
DDAVP6824.1
Secondary and other outcome results(1)
Secondary outcomeNumber· within 6 hours of study treatment

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%)

GroupValue (participants)
DDAVP2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
DDAVPDDAVP 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–2 / 140 / 14

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2014

Desmopressin improves platelet activity in acute intracerebral hemorrhage.

Naidech et al. 2014Strokecited by 78

PMID 25005444PMC6211162DOI 10.1161/strokeaha.114.006061PUB-25005444

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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