Traumatic Brain InjuryPhase 1NCT01363583
Study on the Effect of Prostacyclin Compared to Placebo in Traumatic Brain Injury
A Phase 1 study testing epoprostenol versus normal saline and normal saline in people with Traumatic Brain Injury, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- epoprostenol versus normal saline and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2002to Dec 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- traumatic brain injury, Glasgow coma scale ≤ 8
Who cannot join
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prostacyclin Treatment in Severe Traumatic Brain Injury: a Microdialysis and Outcome Study
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- epoprostenol versus normal saline, normal saline
- Keywords
- traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoprostenol versus normal salineDrug
Also called Flolan®, Normal saline
0.5 ng/kilogram/minute during 4 days
normal salineDrug
0.5-1.5 ml/hour during 4 days
| Study group | Role | What they receive |
|---|---|---|
| epoprostenol, Flolan® | Active comparator | Measurement on the effect of epoprostenol on lactate/pyruvate ratio measured by cerebral microdialysis Receives: Drug: epoprostenol versus normal saline |
| normal saline | Placebo comparator | Effect of saline on the lactate/pyruvate ratio measured by cerebral microdialysis Receives: Drug: epoprostenol versus normal saline; Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo
Measured: 24 hours
Secondary outcomes (1)
Levels of systemic inflammatory markers
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startJan 2002
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Investigators
- Lars-Owe Koskinen, Professor, Principal investigator, Umea university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363583
- Sponsor's protocol ID
- 151:633=01
- Status last verified
- Sep 2001
- First submitted
- 27 May 2011
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19226191Hagglund 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.
PubMed 34914037Olivecrona 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.
PubMed 25518864Wahlstrom 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.
PubMed 24600548
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostacyclin Treatment in Severe Traumatic Brain Injury: a Microdialysis and Outcome Study
- ClinicalTrials.gov ID
- NCT01363583
- Acronym / sponsor ID
- 151:633=01
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 1 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epoprostenol, Flolan® | Active comparator | Drug: epoprostenol versus normal salineMeasurement on the effect of epoprostenol on lactate/pyruvate ratio measured by cerebral microdialysis |
| normal saline | Placebo comparator | Drug: epoprostenol versus normal saline, Drug: normal salineEffect of saline on the lactate/pyruvate ratio measured by cerebral microdialysis |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- traumatic brain injury, Glasgow coma scale ≤ 8
Key exclusion criteria (1 listed)
- pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epoprostenol versus normal salineAlso: Flolan®, Normal saline0.5 ng/kilogram/minute during 4 days | Drug | epoprostenol, Flolan®, normal saline |
| normal saline0.5-1.5 ml/hour during 4 days | Drug | normal saline |
Primary outcome
Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo
Time frame: 24 hours
1 secondary outcome
Levels of systemic inflammatory markers
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
- Results publication: PubMed 19226191Olivecrona 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.
- Derived from this study: PubMed 34914037Hagglund 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.
- Derived from this study: PubMed 25518864Olivecrona 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.
- Derived from this study: PubMed 24600548Wahlstrom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars-Owe Koskinen, Professor principal investigator
Umea university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing epoprostenol versus normal saline and normal saline in people with Traumatic Brain Injury, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01363583, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2011.