The usefulness of measuring oxygen and metabolites in the brain after aneurysm rupture in preventing secondary stroke

The effectiveness of invasive neuromonitoring in high-grade subarachnoid hemorrhage patients - a prospective cohort study

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16523175

Enrollment

200

Registered

2019-08-21

Start date

2018-07-25

Completion date

Unknown

Last updated

2021-09-20

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

Conditions

Delayed cerebral ischemia occurring after subarachnoid hemorrhage. Circulatory System Sequelae of subarachnoid haemorrhage

Interventions

This being an observational trial, all patients are treated according to the hospitals/departments standard operating procedure. We are comparing two historical groups of which data has been collected

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Suffered an aneurysmal subarachnoid hemorrhage. 2. Aged between 18 and 99 years old. 3. The hemorrhage has to present with a Hund & Hess grade of 3 or higher.

Exclusion criteria

Exclusion criteria: 1. The occurrence of early angiographical vasospasms in the first diagnostic angiography. 2. Subarachnoid hemorrhage not cause by aneurysm rupture.

Design outcomes

Primary

Measure	Time frame
Clinical outcomes as measured using the extended Glasgow outcome scale after 12 months. Data is collected prospectively during regular follow-ups and missing information is either appended by analysis of patients files or a structured telephone interview by a blinded assessor.	—

Secondary

Measure	Time frame
1. GOS-E at discharge; GOS-E at 6 months measured and evaluated as mentioned above. 2. Overall mortality. 3. The lag between ictus and first treatment triggering DCI event (days), as is clear from patients files. 4. The absolute number of CT investigations performed during the DCI time frame, in every patient. This as an indirect measurement of reliance in clinical decision making, on the measurements made by the invasive monitoring. 5. The prevalence of silent infarctions (the occurrence of a demarcated infarction as the first sign of ongoing DCI). This is measured by investigation of patients CT and/or MRI images by a blinded observer. 6. The prevalence of overall DCI related infarction as is apparent in clinical files and medical imaging. 7. The prevalence of DCI related mortality, as is apparent in clinical files.	—

Measure

Time frame

1. GOS-E at discharge; GOS-E at 6 months measured and evaluated as mentioned above. 2. Overall mortality. 3. The lag between ictus and first treatment triggering DCI event (days), as is clear from patients files. 4. The absolute number of CT investigations performed during the DCI time frame, in every patient. This as an indirect measurement of reliance in clinical decision making, on the measurements made by the invasive monitoring. 5. The prevalence of silent infarctions (the occurrence of a demarcated infarction as the first sign of ongoing DCI). This is measured by investigation of patients CT and/or MRI images by a blinded observer. 6. The prevalence of overall DCI related infarction as is apparent in clinical files and medical imaging. 7. The prevalence of DCI related mortality, as is apparent in clinical files.

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026