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

Recruiting

• Conditions: I60; S06; Subarachnoid haemorrhage; Intracranial injury

• Registration Number: DRKS00008981
• Lead Sponsor: niversitätsklinik Freiburg, Klinik für Anästhesiologie und Intensivmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 190

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Patient population: HO-1 expression (real-time PCR) in relation to the clinical-neurological long-term result (modified Rankin scale, mRS).<br>2. Patient population: renal failure rate in patients with vs. without traumatic brain injury.<br>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 Outcome Measures

Name	Time	Method
1. HO-1 expression in relation to the hematoma volume (CT examination)<br>2. HO-1 expression in relation to neuroinflammation (cytokine measurement in cerebrospinal fluid)<br>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).<br>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.<br>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.