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This study is a prospective consecutive double-blinded randomized study on the effect of PGI2, prostacyclin (epoprostenol, Flolan®) versus placebo (saline)in patients with severe traumatic brain injury. All patients with severe traumatic brain injury were eligible for inclusion. Inclusion criteria: verified traumatic brain injury, Glasgow Coma Score (GCS) at intubation and sedation of ⤠8, age 15-70 years, a first-recorded cerebral perfusion pressure (CPP) of > 10 mm Hg, and arrival within 24 hours after trauma.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| epoprostenol, FlolanĀ® | Active Comparator | Measurement on the effect of epoprostenol on lactate/pyruvate ratio measured by cerebral microdialysis |
|
| normal saline | Placebo Comparator | Effect of saline on the lactate/pyruvate ratio measured by cerebral microdialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epoprostenol versus normal saline | Drug | 0.5 ng/kilogram/minute during 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of systemic inflammatory markers | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars-Owe Koskinen, Professor | Umea university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umea university | UmeƄ | 90187 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19226191 | Result | 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. | |
| 34914037 | Derived | 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. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011464 | Epoprostenol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D044062 | Prostaglandins I |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| normal saline | Drug | 0.5-1.5 ml/hour during 4 days |
|
| 25518864 | Derived | 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. |
| 24600548 | Derived | 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. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |