An observational study in Subarachnoid Hemorrhage, Hypoxia Ischemia, Cerebral and TBI, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-28.
Sponsored by Odense University Hospital · Observational
Among 22 studies in Subarachnoid Hemorrhage with a site in Denmark — 2 open to participants now, 2 under way, none of them phase 3. Subarachnoid Hemorrhage · Denmark.
Among the 22 studies in Subarachnoid Hemorrhage with a site in Denmark, this one is the only one that started in 2017, is one of 9 observational ones, and was the 9th registered.
510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.
This study's enrollment of 12 is below the median of 120 across 226 observational studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →2 of the 22 studies in Subarachnoid Hemorrhage with a site in Denmark are open now, in 1 country. Each count lists the studies.
Of the 89 Subarachnoid Hemorrhage studies recruiting now, 56 (63%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2017.
Median enrollment 90 across the 13 interventional studies, 70 across the 9 observational. Of the 16 that completed or were terminated, 1 (6%) have results posted.
3 of 22 have an industry lead sponsor. The 7 most frequent:
Odense University Hospital is the lead sponsor of 479 studies on the registry; 110 are open to participants now.
Odense University Hospital has 2 studies filed under Subarachnoid Hemorrhage — fewer than ten, so there is no comparison to draw.
1 of the studies in Subarachnoid Hemorrhage with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06032533Aarhus University HospitalRemote Ischemic Conditioning in Aneurysmal SAH | 2027-11-30 |
Among the 22 studies in Subarachnoid Hemorrhage with a site in Denmark, from their registry updates:
Nothing recorded among them since 2026-09-25.
The first aim of this study is to investigate the frequency and severity of a specific pathological metabolic pattern, mitochondrial dysfunction, of the brain in comatose patients under neurocritical care. This pattern is recognized as a complication after compromised blood flow to the brain and may be amenable to treatment. The other main aim of this study is to correlate patterns of metabolites between brain and jugular venous blood. It is probable but not proven that jugular venous microdialysis can mirror the global metabolic state of the brain.
Purpose
To describe the incidence of cerebral mitochondrial dysfunction in comatose patients admitted to the Neurointensive Care Unit (NICU) at Odense University Hospital and to evaluate the possible correlations between cerebral and jugular bulb microdialysis in an effort to develop new, effective and less invasive diagnostical tools for relevant patient groups.
Background
The hallmark of several serious neurological and neurosurgical disorders including severe traumatic brain injury, intracranial haemorrhage, cerebral infection and global hypoxic injury after cardiac arrest, is that the primary insult is out of reach for therapeutic intervention. Secondary injuries however, ensuing in the days to weeks after the primary insult are amenable to prevention or treatment. Inflammation, transient ischemia, free radical formation, cellular Ca2+-influx and mitochondrial dysfunction are therefore all examples of current research topics in neurointensive care.
The research group has a long history of experimental and clinical work in the area of cerebral metabolism in neurocritical disease. In recent years neuromonitoring with cerebral microdialysis has been a main focus, as well as mitochondrial dysfunction as a possible therapeutic target . In 2004 the investigators showed how monitoring SAH-patients with cerebral microdialysis could predict delayed neurological deterioration/vasospasm related complications, results that were corroborated by later external studies. In 2012 and 2014, results have been published showing how to diagnose mitochondrial dysfunction on the basis of the biochemical patterns of cerebral microdialysis experimentally as well as clinically. Briefly, a cerebrochemical pattern with elevated lactate/pyruvate-ratio with simultaneous normal or supranormal levels of pyruvate and glucose seen together with normal tissue oxygen monitoring indicates mitochondrial dysfunction. Mitochondrial dysfunction most likely plays a key role in the worsening of outcome in a variety cerebral pathological conditions, and might be amenable to pharmacologic intervention.
The microdialysis technique is based on a thin probe with a semipermeable membrane being inserted in affected brain tissue, collecting interstitial fluid from a small area surrounding the probe. The fluid is analysed for metabolites, proteins or pharmacological substances and has earlier been shown to be of great value in guiding NICU care and prognostication. One problem with the technique is, however, that the measurements are regional and limited to the very small sampling volume of the probe. Another obstacle is that the technique is intracranial invasive.
Aims
In the current prospective cohort study, the investigators will describe the incidence of mitochondrial dysfunction in a patients admitted to the NICU with severe subarachnoid haemorrhage (SAH). As patients suffering from SAH often have a non-ischemic cerebral metabolic affliction, a global cerebral measurement would presumably be as useful or more so than a focal measurement from only a very small regional brain volume. The investigators wish to evaluate a new method of monitoring, namely microdialysis of cerebral venous blood drainage. The cerebral venous drainage passes almost without exception through the jugular bulbs, left or right sided majority depending on dominance. The investigators will compare results of regional cerebral and venous measurements in order to confirm the hypothesis that metabolic disturbances of the brain are mirrored in the venous blood drainage in the jugular bulb. A pilot study of patients undergoing open heart surgery has confirmed significant differences in lactate and pyruvate in arterial systemic vs jugular venous blood. Yet unpublished data from this groups porcine experimental model supports the possibility of global metabolic venous monitoring.
Perspectives
If jugular bulb microdialysis can be confirmed to give a reliable global estimate of cerebral metabolic state it might be possible to a implement a new, less invasive diagnostic tool for NICU-patients. Surrogate measures in use today as e.g. NIRS (Near Infrared Spectroscopy) correlate poorly to cerebral metabolic status.
Patients admitted to the neurointensive care unit at Odense University Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Correlations of lactate/pyruvate-ratio (LP-ratio) calculated by dividing lactate concentration in mM by pyruvate concentration in mikroM, in cerebral and venous microdialysis
Hourly samples of lactate (mM) and pyruvate (mikroM) are assessed using microdialysis measurements in brain and jugular bulb. The LP-ratio is calculated and compared at each timepoint.
Time frame: Patients are monitored a mean of 5 days with hourly analysis.
Correlations of microdialysis values of glucose.
Cerebral and jugular bulb microdialysis measurements of glucose (mM)compared for co-variation.
Time frame: Mean 5 day measurements
Modified Rankin scale of outcome.
6 month modified Rankin Scale (mRS) will be assessed at outpatient clinic. The mRS is the most widely used scale for measuring degree of disability in stroke trials, The scale ranges from 0 to 6, where 0 means no symptoms and 6 is dead.
Time frame: 6 months
Evaluation of mitochondrial dysfunction under study period.
Microdialysis results will be analysed for amount (hours) of mitochondrial dysfunction, defined as normal cerebral P02-measurements (mmHg), in combination with high LP-ratio (ratio) and simultaneous normal or high pyruvate concentration (mikroM).
Time frame: calculations based on mean 5-day measurements per patient.
Plan to share: Undecided
Ran from Aug 2017 to primary completion in Jul 2018, 10 months.
Of 116 non-industry observational studies under Subarachnoid Hemorrhage, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 127. This study's 10 months is below that.
Counting every sponsor, half of 119 studies reached it within 40 months; a quarter within 19 and three quarters within 127.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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