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Study on the Effect of Prostacyclin Compared to Placebo in Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
epoprostenol versus normal saline
normal saline
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • traumatic brain injury, Glasgow coma scale ≤ 8

Exclusion Criteria:

  • pregnant or lactating women

Sites / Locations

  • Umea university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

epoprostenol, Flolan®

normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Levels of systemic inflammatory markers

Full Information

First Posted
May 27, 2011
Last Updated
May 27, 2011
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT01363583
Brief Title
Study on the Effect of Prostacyclin Compared to Placebo in Traumatic Brain Injury
Official Title
Prostacyclin Treatment in Severe Traumatic Brain Injury: a Microdialysis and Outcome Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2001
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Umeå University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
traumatic brain injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
epoprostenol, Flolan®
Arm Type
Active Comparator
Arm Description
Measurement on the effect of epoprostenol on lactate/pyruvate ratio measured by cerebral microdialysis
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
Effect of saline on the lactate/pyruvate ratio measured by cerebral microdialysis
Intervention Type
Drug
Intervention Name(s)
epoprostenol versus normal saline
Other Intervention Name(s)
Flolan®, Normal saline
Intervention Description
0.5 ng/kilogram/minute during 4 days
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
0.5-1.5 ml/hour during 4 days
Primary Outcome Measure Information:
Title
Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Levels of systemic inflammatory markers
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: traumatic brain injury, Glasgow coma scale ≤ 8 Exclusion Criteria: pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars-Owe Koskinen, Professor
Organizational Affiliation
Umea university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umea university
City
Umea
ZIP/Postal Code
90187
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
19226191
Citation
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.
Results Reference
result
PubMed Identifier
34914037
Citation
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.
Results Reference
derived
PubMed Identifier
25518864
Citation
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.
Results Reference
derived
PubMed Identifier
24600548
Citation
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.
Results Reference
derived

Learn more about this trial

Study on the Effect of Prostacyclin Compared to Placebo in Traumatic Brain Injury

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