Study on the Effect of Prostacyclin Compared to Placebo in Traumatic Brain Injury
NCT ID: NCT01363583
Last Updated: 2011-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2002-01-31
2005-12-31
Brief Summary
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Tne primary aim was to evaluate whether treatment with epoprostenol would reduce a lactate/pyruvate ratio,as measured by cerebral microdialysis after 24 hours of treatment.
A secondary aim was to evaluate the effect of epoprostenol on systemic inflammatory markers, measured by different cytokines.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
QUADRUPLE
Study Groups
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epoprostenol, Flolan®
Measurement on the effect of epoprostenol on lactate/pyruvate ratio measured by cerebral microdialysis
epoprostenol versus normal saline
0.5 ng/kilogram/minute during 4 days
normal saline
Effect of saline on the lactate/pyruvate ratio measured by cerebral microdialysis
epoprostenol versus normal saline
0.5 ng/kilogram/minute during 4 days
normal saline
0.5-1.5 ml/hour during 4 days
Interventions
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epoprostenol versus normal saline
0.5 ng/kilogram/minute during 4 days
normal saline
0.5-1.5 ml/hour during 4 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
15 Years
70 Years
ALL
No
Sponsors
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Umeå University
OTHER
Responsible Party
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Umea university
Principal Investigators
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Lars-Owe Koskinen, Professor
Role: PRINCIPAL_INVESTIGATOR
Umea university
Locations
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Umea university
Umeå, , Sweden
Countries
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References
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Olivecrona M, Rodling-Wahlstrom M, Naredi S, Koskinen LO. Prostacyclin treatment in severe traumatic brain injury: a microdialysis and outcome study. J Neurotrauma. 2009 Aug;26(8):1251-62. doi: 10.1089/neu.2008.0605.
Hagglund L, Olivecrona M, Koskinen LD. Correlation of Cerebral and Subcutaneous Glycerol in Severe Traumatic Brain Injury and Association with Tissue Damage. Neurocrit Care. 2022 Jun;36(3):993-1001. doi: 10.1007/s12028-021-01412-z. Epub 2021 Dec 16.
Olivecrona Z, Bobinski L, Koskinen LO. Association of ICP, CPP, CT findings and S-100B and NSE in severe traumatic head injury. Prognostic value of the biomarkers. Brain Inj. 2015;29(4):446-54. doi: 10.3109/02699052.2014.989403. Epub 2014 Dec 18.
Wahlstrom MR, Olivecrona M, Ahlm C, Bengtsson A, Koskinen LO, Naredi S, Hultin M. Effects of prostacyclin on the early inflammatory response in patients with traumatic brain injury-a randomised clinical study. Springerplus. 2014 Feb 18;3:98. doi: 10.1186/2193-1801-3-98. eCollection 2014.
Other Identifiers
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151:633=01
Identifier Type: -
Identifier Source: org_study_id
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