Intracerebral haemorrhage Circulatory System Intracerebral haemorrhage
Conditions
Interventions
Treatment
All patients in both study groups receive standard neurointensive care, following the recommendations of current guidelines and the agreements from a consensus meeting of the steering board.
Sponsors
University Hospital Erlangen (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years 2. Diagnosis of large acute primary ICH 3. ICH located at the level of the basal ganglia or thalamus 4. Large ICH is defined by between 25 and 64 ml on the initial cranial computertomography (cCT). Since cranial magnetic resonance imaging (MRI) techniques overestimate intracerebral haematoma size, patients with a haematoma size of 35 to 74 ml can be included if the initial tomography of the brain is an MRI. 5. Glasgow Coma Scale (GCS) of less than 8 before intubation or worsening of clinical symptoms defined by a decrease of 2 points on the GCS Patients who are randomised should be treated earliest 6 hours and up to 18 hours after symptom onset. Before randomisation, patients do not have to show clinical signs of herniation such as bilateral signs of the pyramidal tract or pupillomotory defects. Informed consent has to be given before randomisation by the patients or the legal entity.
Exclusion criteria
Exclusion criteria: 1. ICH is located in the posterior cranial fossa or extends to the brainstem 2. Patients with additional intraventricular haemorrhage (IHV) and the need for external ventricular drainage (EVD) due to an occlusive hydrocephalus, as IVH is an independent prognostic factor for poor outcome. However, if the local clinical guidelines of the investigator address treatment of IVH by EVD, intraventricular clot lysis and use of lumbar drainage, also patients with additional IVH can be included. 3. Patients with suspected secondary cause of ICH such as vascular malformation, brain tumour, metastasis, impaired coagulation (International Normalised Ratio [INR] greater than 1.5) and a thrombocyte count of below 70,000/ul 4. Patients with a body weight of over 130 kg, severe known heart disease such as severe dilatative cardiomyopathy or severe valve disease, known haematological disease (especially cryoglobulinaemia), vasospastic disease, paramyotonia congenital, severe liver or kidney disease and myocardial infarct within the last 3 weeks 5. Patients with severe comorbidity defined by a Modified Rankin Scale (mRS) of greater than 3 and severe infection defined by leukocytosis of over 20,000/ul 6. Female patients with an age below 45 will have to have a negative urinary test for pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mortality on day 30 after ICH 2. Total lesion volume (volume of ICH and PHE) on day 8±0.5 and day 11±0.5 after ICH | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality during treatment in the study centre ("in-hospital-mortality") 2. Mortality on day 90 and 180 after ICH 3. Dichotomised modified Rankin Scale (mRS): for 0 - 3 versus 4 - 6 and 0 - 2 versus 3 - 6 after 3 and 6 months 4. Barthel Index 3 and 6 months after ICH 5. Complications attributed to hypothermia, and hypothermia associated procedures (e.g. bleeding or infection due to endovascular catheter) | — |
Countries
Austria, Germany
Outcome results
None listed