NCT01363583

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2011

Completed
Last Updated

June 1, 2011

Status Verified

September 1, 2001

Enrollment Period

3.9 years

First QC Date

May 27, 2011

Last Update Submit

May 27, 2011

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo

    24 hours

Secondary Outcomes (1)

  • Levels of systemic inflammatory markers

    4 days

Study Arms (2)

epoprostenol, Flolan®

ACTIVE COMPARATOR

Measurement on the effect of epoprostenol on lactate/pyruvate ratio measured by cerebral microdialysis

Drug: epoprostenol versus normal saline

normal saline

PLACEBO COMPARATOR

Effect of saline on the lactate/pyruvate ratio measured by cerebral microdialysis

Drug: epoprostenol versus normal salineDrug: normal saline

Interventions

epoprostenol versus normal salineDRUG

0.5 ng/kilogram/minute during 4 days

Also known as: Flolan®, Normal saline
epoprostenol, Flolan®normal saline
normal salineDRUG

0.5-1.5 ml/hour during 4 days

normal saline

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • traumatic brain injury, Glasgow coma scale ≤ 8

You may not qualify if:

  • pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umea university

Umeå, 90187, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 19226191RESULT

  • 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.

    PMID: 34914037DERIVED

  • 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.

    PMID: 25518864DERIVED

  • 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.

    PMID: 24600548DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

EpoprostenolSaline Solution

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Prostaglandins IProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Lars-Owe Koskinen, Professor

    Umea university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 1, 2011

Study Start

January 1, 2002

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

June 1, 2011

Record last verified: 2001-09

Locations

SE(1)