Intracerebral HemorrhagePhase 2IMPACTNCT00961532
Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept
A Phase 2 study testing DDAVP injection (desmopressin acetate) in people with Intracerebral Hemorrhage, run by Northwestern University at 1 site in United States.
Trial summary
The investigators intend to show that DDAVP improves platelet activity from baseline to 60 minutes after treatment start. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- DDAVP injection (desmopressin acetate)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
The investigators intend to show that DDAVP improves platelet activity from baseline to 60 minutes after treatment start.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- DDAVP injection (desmopressin acetate)
- Keywords
- intracerebral hemorrhage, platelets
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDAVP injection (desmopressin acetate)Drug
0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| DDAVP | Experimental | DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes Receives: Drug: DDAVP injection (desmopressin acetate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes after treatment start
Secondary outcomes (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%)
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.
Measured: within 6 hours of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Memorial Hospital
- Responsible party
- Principal investigator, Andrew Naidech, Northwestern University
- Investigators
- Andrew M Naidech, MD MSPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961532
- Sponsor's protocol ID
- STU8168
- Acronym
- IMPACT
- Status last verified
- Jul 2014
- First submitted
- 17 Aug 2009
- Last updated
- 28 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Naidech AM, Maas MB, Levasseur-Franklin KE, Liotta EM, Guth JC, Berman M, Rosenow JM, Lindholm PF, Bendok BR, Prabhakaran S, Bernstein RA, Kwaan HC. Desmopressin improves platelet activity in acute intracerebral hemorrhage. Stroke. 2014 Aug;45(8):2451-3. doi: 10.1161/STROKEAHA.114.006061. Epub 2014 Jul 8.
PubMed 25005444
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept
- ClinicalTrials.gov ID
- NCT00961532
- Acronym / sponsor ID
- IMPACT / STU8168
- Conditions
- Intracerebral Hemorrhage
- Keywords
- intracerebral hemorrhage, platelets
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Northwestern Memorial Hospital
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Posted 28 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators intend to show that DDAVP improves platelet activity from baseline to 60 minutes after treatment start.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DDAVP | Experimental | Drug: DDAVP injection (desmopressin acetate)DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DDAVP injection (desmopressin acetate)0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes | Drug | DDAVP |
Primary outcome
Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment
Time frame: 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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25005444Naidech AM, Maas MB, Levasseur-Franklin KE, Liotta EM, Guth JC, Berman M, Rosenow JM, Lindholm PF, Bendok BR, Prabhakaran S, Bernstein RA, Kwaan HC. Desmopressin improves platelet activity in acute intracerebral hemorrhage. Stroke. 2014 Aug;45(8):2451-3. doi: 10.1161/STROKEAHA.114.006061. Epub 2014 Jul 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew M Naidech, MD MSPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DDAVP injection (desmopressin acetate) in people with Intracerebral Hemorrhage, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment (time frame: 60 minutes after treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00961532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2014.