Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion
NCT00538616
ABOUT THIS STUDY
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Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- primary diagnosis of Traumatic Brain Injury (TBI), Subarachnoid Hemorrhage (SAH),Intracranial Hemorrhage (ICH), stroke
- Must require (be on) mechanical ventilation
- must require (have in place) intracranial pressure (ICP) monitoring
- must require (be receiving) continuous IV sedation
- Bleeding diathesis
- Glasgow Coma Scale (GCS) < 5 with fixed pupils
- Pregnant
- elevated ICP that requires deep sedation
- pulmonary instability
- Hx of Ethanol(ETOH) abuse that requires current benzodiazepine treatment for delirium
- allergy to propofol or precedex
- status epilepticus
- current neuromuscular blockade
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Descriptive Information | |||||||
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Brief Title ICMJE | Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion | ||||||
Official Title ICMJE | A Phase IV Single Center Cross Over Clinical Study Comparing Two Different Sedations Strategies for Mechanically Ventilated Patients With Neurological Critical Illness | ||||||
Brief Summary | The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam. | ||||||
Detailed Description | The hypothesis is that a neurologic exam performed when the subject has continuous infusion of precedex will result in less brain injury (where the lactate/pyruvate ratio indicates injury) then when a neurologic exam is performed on subjects receiving propofol, because that exam requires that the propofol infusion be stopped. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Participant) Primary Purpose: Treatment | ||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 8 | ||||||
Original Enrollment ICMJE | Not Provided | ||||||
Actual Study Completion Date ICMJE | April 2010 | ||||||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00538616 | ||||||
Other Study ID Numbers ICMJE | Pro00002077 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Carmelo Graffagnino, Duke University | ||||||
Study Sponsor ICMJE | Carmelo Graffagnino | ||||||
Collaborators ICMJE | Hospira, now a wholly owned subsidiary of Pfizer | ||||||
Investigators ICMJE |
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PRS Account | Duke University | ||||||
Verification Date | March 2013 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |