Cooling in INtraCerebral Haemorrhage (CINCH) trial: a multicentre, controlled, prospective, randomised, blinded endpoint assessment

niversity Hospital Erlangen (Germany)0 个研究点目标入组 50 人开始时间: 2011年2月18日最近更新: 2015年1月13日

试验速览

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•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.

•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

发起方

niversity Hospital Erlangen (Germany)