Subarachnoid Hemorrhage Clinical Trial
Official title:
Changes in Morphine Handling and Response in Patients With Brain Trauma
Verified date | September 2006 |
Source | Dalhousie University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Hypothesis: During severe brain trauma (injury, surgery) the ensuing inflammatory response in the central nervous system (CNS) results in a decrease in the expression of the transporter protein p-glycoprotein (PGP) in the blood brain barrier. This loss results in the penetration into the brain of certain drugs that are normally excluded by the transporter protein. In this study the working hypothesis is that the agitation observed in patients with CNS trauma treated with morphine is related to the inflammation evoked loss of PGP in the blood brain barrier and the accumulation of the morphine metabolite 3-morphine glucuronide.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | April 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Sustained a head trauma (closed head injury or subarachnoid hemorrhage [SAH]) - Fitted with a intraventricular drainage catheter - Currently being treated with morphine Exclusion Criteria: - Patient is receiving another PGP inhibitor drug other than morphine or midazolam |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Canada | Capital Health -QE II HSC | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Dalhousie University | Canadian Institutes of Health Research (CIHR) |
Canada,
Goralski KB, Hartmann G, Piquette-Miller M, Renton KW. Downregulation of mdr1a expression in the brain and liver during CNS inflammation alters the in vivo disposition of digoxin. Br J Pharmacol. 2003 May;139(1):35-48. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | see the ratios of cerebrospinal fluid (CSF)/blood increase with time as the inflammation progresses | prospective | ||
Secondary | ratios of morphine and its metabolites in CSF and blood with the RASS will determine if observed CNS stimulation occurs at a time when the levels of 3-morphine glucuronide is high on the brain side of the blood brain barrier | prospective |
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