"brain haemorrhage" "intracerebral haemorrhage"
Conditions
Interventions
Group1. No induced hypertension: patients will not be treated with induced
hypertension when DCI develops. Hypotension (mean arterial pressure (MAP) below
80 mmHg) will be prevented. In order to ach
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Admission to the hospital 2. Age 18 years or over 3. Aneurysmal SAH, demonstrated on CT-angiography or cerebral angiograph 4. DCI (decrease of at least one point on the GSC sumscore, unless the decrease doesn*t reflect DCI as evaluated by the treating physician, and/or all new neurological focal deficits), diagnosed by a neurologist, neurosurgeon or intensivist, 5. Informed consent
Exclusion criteria
Exclusion criteria: 0. Evidence of DCI after the SAH at time of asking for informed consent, unless symptoms of DCI started within 3 hours 1. Co-existing severe head injury. 2. A perimesencephalic haemorrhage. 3. A history of a ventricular cardiac rhythm disorder, necessitating medical treatment. 4. A history of left ventricular heart failure, necessitating medical treatment. 5. Pregnancy. 6. Transferral to another hospital, 7. moribund, 8. Other cause for neurological deterioration (see page 19 of the study protocol for the differential diagnosis) 9. Symptomatic cerebral aneurysm not yet treated by coiling or clipping, 10. Severe hypertension, defined as a spontaneous MAP of 120 mmHg or more at the moment of evaluation for trial participation, 11. Any contraindication for induced hypertension (such as a cardiac complication necessitating medical treatment) as evaluated by the treating physician. And furthermore, in selected centres where the sub study with CT perfusion will be performed: 12. known allergy for CT-contrast agents. 13. renal failure, defined as a serum creatinine > 150 µmol/l, because of the risk of contrast nephropathy. 14. diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter will be the proportion of SAH patients with DCI with poor outcome three months after the SAH, defined as a modified Rankin Scale score of 3 or more. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are related to treatment failure, functional outcome, adverse events and to the influence on cerebral haemodynamics. Related to treatment failure: proportion of patients in the induced hypertension group in which induced hypertension did not give clinical improvement of symptoms of DCI within 24 hours. Related to the functional condition: case fatality 30 days after SAH, Activities of daily living (ADL), three months after the SAH assessed with the Barthel Index, Quality of life, three months after the SAH, estimated with the Stroke Specific Quality of Life Scale (SSQoL-12-NL). Anxiety and depression, three months after the SAH, assessed with the Hospital Anxiety and Depression Scale (HADS). Cognitive functioning, three months after the SAH, evaluated by the Cognitive Failures Questionnaire (CFQ). Functional outcome twelve months after the SAH, assessed with the modified Rankin Scale. Related to adverse effects: Complications related to insertion of a central venous catheter or intra-arterial catheter (including local haemorrhage and pneumothorax). Intracranial complications related to induced hypertension (such as exacerbation of cerebral oedema, hemorrhagic infarction and bleeding of an asymptomatic aneurysm). Systemic complications related to induced hypertension (including cardiac rhythm disorders, low cardiac output state and cardiac ischemia). Related to the influence on cerebral haemodynamics: The difference in CBF, CBV, TTP and MTT between the intervention and the control groups 24-36 hours after the start of the study (i.e. CTP-2). The difference in CBF, CBV, TTP and MTT between the perfusion CT-scan (at baseline, the moment of deterioration, i.e. CTP-1) and the second perfusion CT-scan (CTP-2) within the same patients. | — |
Countries
Netherlands
Outcome results
None listed