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The role of heme oxygenase 1 (HO-1) for hematoma resolution, neuroinflammation, circadian rhythm and clinical outcome after hemorrhagic or traumatic brain injury

The role of heme oxygenase 1 (HO-1) for hematoma resolution, neuroinflammation, circadian rhythm and clinical outcome after hemorrhagic or traumatic brain injury - The role of heme oxygenase 1 in brain injury

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00008981
Enrollment
190
Registered
2015-07-31
Start date
2015-09-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I60 S06

Interventions

Group 1: In patients with subarachnoid hemorrhage we will obtain blood and cerebrospinal fluid samples from existing access tubes at different time points (day 1, day 7, day 14 after hemorrhage occurr

Sponsors

Universitätsklinik Freiburg, Klinik für Anästhesiologie und Intensivmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: SAH patients: 1. Adults (> 18 years) male or female persons. 2. Detection of SAH by imaging or in the cerebrospinal fluid (lumbar puncture with blood / xanthochromia). 3. Admission to the Freiburg University Hospital within 24 hours of the onset of symptoms. 4. Surgical therapeutic intervention with placement of an EVD / lumbar drainage and a CVC / arterial catheter. 5. Ability to consent, either personally or through an authorized person. Polytrauma +/- traumatic brain injury: 1. Adult patients with polytrauma (ISS> 16) +/- traumatic brain injury 2. Admission to the anesthetic intensive care unit within 24 hours after trauma 3. Ability to consent either in person or by proxy. Severe traumatic brain injury: 1. Adult patients with severe traumatic brain injury (initial point value Glasgow coma scale <8) 2. Admission to the anaesthesiological intensive care unit or neurosurgical intensive care unit within 24 hours after trauma 3. Establishment of an intravascular catheter (arterial line, peripheral or central venous line) within 24 hours after trauma for therapeutic / diagnostic purposes 4. Ability to consent through proxy

Exclusion criteria

Exclusion criteria: SAH patients: 1. Children <18 years. 2. Recording later than 24 hours after the onset of symptoms. 3. The patient dies within 24 hours of admission. 4. Radiographic suspicion of additional subdural or epidural bleeding. 5. Radiographic suspicion of meningitis or encephalitis. 6. pregnant patients. 7. Patients with sepsis, SIRS or other systemic inflammation symptoms. 8. Patients with pre-existing intellectual disabilities. Polytrauma patients: 1. pre-existing kidney damage / impaired kidney function 2. Not taken within 24 hours after trauma 3. Die within 24 hours of admission 4. Traumatic or non-traumatic brain damage within the past 14 days. Patients with severe TBI: 1. Not taken within 24 hours after trauma 2. Die within 24 hours of admission 3. Traumatic or non-traumatic brain damage within the past 14 days

Design outcomes

Primary

MeasureTime frame
1. Patient population: HO-1 expression (real-time PCR) in relation to the clinical-neurological long-term result (modified Rankin scale, mRS). 2. Patient population: renal failure rate in patients with vs. without traumatic brain injury. 3. Patient population: Frequency of distribution of the GOS categories (GOS 1-3 vs. GOS4 & 5) in the patient population with high and low HO-1 expression in peripheral blood (HO-1 high / low patient groups).

Secondary

MeasureTime frame
1. HO-1 expression in relation to the hematoma volume (CT examination) 2. HO-1 expression in relation to neuroinflammation (cytokine measurement in cerebrospinal fluid) 3. HO-1 expression in relation to other potential predictors of the poor long-term neurological outcome (demography, medical history, laboratory values on admission, SAH-dependent variables: Hunt & Hess, Fisher, aneurysm localization, hydrocephalus, cerebral edema, intracerebral hemorrhage). 2. Patient population: Period-2 expression in blood with vs. without traumatic brain injury and with vs. without kidney failure. Correlation with CAM-ICU score, ventilation and ICU duration and survival after 6 months. 3. Patient population: frequency of distribution of the GOS categories (GOS 1-3 vs. GOS4 & 5) in the patient population with high and low circadian gene expression in peripheral blood, correlation with delirium rate, duration of ventilation and sedation, and survival 6 months in relation to the patient categories.

Countries

Germany

Contacts

Public ContactNils Schallner

Universitätsklinik Freiburg, Klinik für Anästhesiologie und Intensivmedizin

nils.schallner@uniklinik-freiburg.de+49-761-270-23060

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 22, 2026