Trial · NCT03318783

Subarachnoid Hemorrhage and Soluble Epoxide Hydrolase Inhibition Trial

NCT03318783, Phase 1, Phase 2, Completed, Oregon Health and Science University; results first posted 2021-01-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Subarachnoid Hemorrhage and Soluble Epoxide Hydrolase Inhibition Trial. Trials, record NCT03318783. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03318783

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Subarachnoid Hemorrhage and Soluble Epoxide Hydrolase Inhibition Trial
NCT number: NCT03318783
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 20 participants, actual
Lead sponsor: Oregon Health and Science University
Conditions: Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia, Vasospasm, Cerebral, Endothelial Dysfunction
Interventions: GSK2256294, Placebo
First posted: 2017-10-24
Last updated: 2021-01-22
Results first posted: 2021-01-22

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Participants With Adverse Events	90 days	Summary tables and listings will be provided for all reported adverse events, defined as adverse events that start on or after the first administration of study drug. The reported adverse event term will be assigned a standardized preferred term. Adverse events will be summarized based on the number and percentage of patients experiencing the event. In the event a patient experiences repeat episodes of the same adverse event, then the event with the highest severity grade and strongest causal relationship to study treatment will be used for purposes of incidence tabulations. All deaths will be reported in a patient listing, which will include the primary cause of death and the number of days between the date of the last dose of study drug and death.
Secondary	Study Day 7 and Study Day 10 Serum and CSF EET/ Dihyroxyeicosatrienoic (DHET) Ratio, by Mass Spectroscopic Analysis (ng/mL)	10 days	Day 7 and day 10 serum EET/DHET ratios will be measured by liquid chromatography and mass spectroscopy of collected blood samples. Day 7 and day 10 CSF EET/DHET ratios will be measured by liquid chromatography and mass spectroscopy of collected CSF samples.
Secondary	Study Day 7 and Study Day 10 Serum Epoxyoctadecenoic Acid (EPOME) to Dihydroxyoctadec-12-enoic Acid (DPOME) Ratio, by Mass Spectroscopic Analysis (ng/mL)	10 days	Study day 7 and study day 10 serum epoxyoctadecenoic acid (EPOME) to dihydroxyoctadec-12-enoic acid (DPOME) ratio, will be measure by mass spectroscopic analysis of collected blood samples.
Secondary	Serum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10	10 days	The following serum biomarkers will be obtained from collected blood samples by Luminex assay: e-selectin, p-selectin, Vascular cell adhesion marker (VCAM-1), Platelet endothelial cell adhesion marker (PECAM-1, CD31), intercellular adhesion molecule (ICAM-1).
Secondary	CSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10	10 days	The following CSF biomarker will be obtained from collected CSF samples by Luminex assay: Tumor necrosis factor alpha (TNF-α) (pg/mL), Interleukin 1β (IL-1β) (pg/mL), Interferon gamma (IFN-γ) (pg/mL), Interleukin 6 (IL-6) (pg/mL), Interleukin 8 (IL-8) (pg/mL), Monocyte chemoattractant protein 1 (MCP-1) (pg/mL)
Other	Hospital Length of Stay in Days	90 days	The hospital length of stay will be recorded in days, at the time of hospital discharge.
Other	Discharge Disposition	90 days	The disposition from the hospital in one of the following categories: home, home with services, rehab, long term acute care facility, skilled nursing facility, hospice, death
Other	Number of Participants With New Stroke on Hospital Discharge Imaging	90 days	The last head CT or other brain imaging to detect the presence of a new area of cerebral infarction will be reviewed at the time of hospital discharge. A cerebral infarction will be defined as a one identified on hospital discharge that was not present on imaging between 24-48 hours after aneurysm occlusion, and not attributable to other causes such as surgical clipping or endovascular treatment. Hypodensities resulting from extraventricular drains or residual intraparencyhmal hematomas will not be considered new strokes.
Other	Modified Rankin Scale (mRS) at Hospital Discharge and 90 Day Follow up	90 days	The mRS score will be determined by patient or surrogate interview, at both hospital discharge and 90 day follow up. Scores will be assigned based on the following: 0 - no symptoms, 1 - no significant disability, able to carry out all usual activities despite some symptoms, 2 - slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 - moderate disability, requires some help, but able to walk unassisted, 4 - moderately severe disability, unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 - severe disability, requires constant nursing care and attention, bedridden, incontinent, 6 - deceased.
Other	Extended Glasgow Outcome Scale (GOSE) Score at 90 Day Follow up	90 days	At 90 day follow up, the GOSE will be determined by patient or surrogate telephone interview, based on a structured interview of 19 questions. The GOSE is a scale of 1-8 where 1 - deceased, 2 - vegetative state, 3 - low severe disability, 4 - upper severe disability, 5 - low moderate disability, 6 -upper moderate disability, 7 - low good recovery, 8 - upper good recovery.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Participants With Adverse Events	90 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Study Day 7 and Study Day 10 Serum and CSF EET/ Dihyroxyeicosatrienoic (DHET) Ratio, by Mass Spectroscopic Analysis (ng/mL)	10 days	Missing data occurred due to no sample collection from the CSF in patients who had external ventricular drains removed as part of their standard ICU care, prior to the study visit for sample collection. Missing serum samples are the result of one patient in the placebo group who died prior to sample collection visit, and multiple unsuccessful attempts at blood collection from another patient.	ration	MEAN
SECONDARY	Study Day 7 and Study Day 10 Serum Epoxyoctadecenoic Acid (EPOME) to Dihydroxyoctadec-12-enoic Acid (DPOME) Ratio, by Mass Spectroscopic Analysis (ng/mL)	10 days	Missing data occurred due to no sample collection from the CSF in patients who had external ventricular drains removed as part of their standard ICU care, prior to the study visit for sample collection. Missing serum samples are the result of one patient in the placebo group who died prior to sample collection visit, and multiple unsuccessful attempts at blood collection from another patient.	ration	MEAN
SECONDARY	Serum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10	10 days	Missing data occurred due to no sample collection from the CSF in patients who had external ventricular drains removed as part of their standard ICU care, prior to the study visit for sample collection. Missing serum samples are the result of one patient in the placebo group who died prior to sample collection visit, and multiple unsuccessful attempts at blood collection from another patient.	ng/mL	MEAN
SECONDARY	CSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10	10 days	Missing data occurred due to no sample collection from the CSF in patients who had external ventricular drains removed as part of their standard ICU care, prior to the study visit for sample collection. Missing serum samples are the result of one patient in the placebo group who died prior to sample collection visit, and multiple unsuccessful attempts at blood collection from another patient.	pg / mL	MEAN
OTHER_PRE_SPECIFIED	Hospital Length of Stay in Days	90 days		days	MEAN
OTHER_PRE_SPECIFIED	Discharge Disposition	90 days		Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants With New Stroke on Hospital Discharge Imaging	90 days		Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Modified Rankin Scale (mRS) at Hospital Discharge and 90 Day Follow up	90 days	One subject in GSK2256294 group lost to followup	units on a scale	MEAN
OTHER_PRE_SPECIFIED	Extended Glasgow Outcome Scale (GOSE) Score at 90 Day Follow up	90 days	Missing data due to one subject in the GSK2256294 lost to followup	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group84

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Participants With Adverse Events	GSK2256294	Venous Thromboembolism	2	Participants
Participants With Adverse Events	Placebo	Venous Thromboembolism	0	Participants
Participants With Adverse Events	GSK2256294	Myocardial Infarction	0	Participants
Participants With Adverse Events	Placebo	Myocardial Infarction	0	Participants
Participants With Adverse Events	GSK2256294	Seizure	1	Participants
Participants With Adverse Events	Placebo	Seizure	1	Participants
Participants With Adverse Events	GSK2256294	Any Documented Infection	4	Participants
Participants With Adverse Events	Placebo	Any Documented Infection	6	Participants
Participants With Adverse Events	GSK2256294	Cerebral Salt Wasting	3	Participants
Participants With Adverse Events	Placebo	Cerebral Salt Wasting	2	Participants

1 to 10 of 84Source ClinicalTrials.gov

See all 84 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	GSK2256294	10
Overall Study	STARTED	Placebo	10
Overall Study	COMPLETED	GSK2256294	10
Overall Study	COMPLETED	Placebo	8
Overall Study	NOT COMPLETED	GSK2256294	0
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Delayed Cerebral Ischemia	Nervous system disorders	GSK2256294	2	10	2
serious	Delayed Cerebral Ischemia	Nervous system disorders	Placebo	1	9	1
serious	Rebleed of Unsecured Aneurysm	Nervous system disorders	GSK2256294	0	10	0
serious	Rebleed of Unsecured Aneurysm	Nervous system disorders	Placebo	1	9	1
serious	Aspiration Pneumonia	Infections and infestations	GSK2256294	1	10	1
serious	Aspiration Pneumonia	Infections and infestations	Placebo	1	9	1
serious	Leukopenia	Blood and lymphatic system disorders	GSK2256294	0	10	0
serious	Leukopenia	Blood and lymphatic system disorders	Placebo	1	9	1
serious	Deep Vein Thrombosis	Blood and lymphatic system disorders	GSK2256294	2	10	2
serious	Deep Vein Thrombosis	Blood and lymphatic system disorders	Placebo	0	9	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GSK2256294	0	10
Total, all-cause mortality	Placebo	1	9
Total, other adverse events	GSK2256294	0	10
Total, other adverse events	Placebo	0	10
Total, serious adverse events	GSK2256294	4	10
Total, serious adverse events	Placebo	5	9

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34873674	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
GSK2256294 vs Placebo: Number of Participants With New Stroke on Hospital Discharge Imaging	Trial comparisons
GSK2256294 vs Placebo: deaths from any cause	Trial comparisons
GSK2256294 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03318783

GET https://conductscience.org/api/trials/v1/NCT03318783/results?page=2

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