COOLing for Ischaemic Stroke Trial. A phase II randomised clinical trial.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

1. A clinical diagnosis of acute ischaemic stroke;
2. A possibility to initiate cooling within 4.5 hours of stroke onset. Onset time for patients who awoke with symptoms is defined as the last time the patient was awake without symptoms of stroke;
3. Score on the National Institutes of Health Stroke Scale (NIHSS) >= 6;
4. Age >= 18 years;
5. Written informed consent by the patient or a legal representative.

Exclusion Criteria

1. Evidence from a CT or MRI scan or from other pre-randomisation investigations of an intracranial haemorrhage, a brain tumour, encephalitis, or any diagnosis other than acute ischaemic stroke likely to be the cause of the symptoms. Haemorrhagic transformation of the infarct is not an exclusion criterion, except when there is a parenchymal haematoma covering more than 30% of the infarcted area, with significant space-occupying effect, or when there is a bleeding remote from the infarcted area (PH2 on Fiorelli*s scale);
2. Conditions that may be complicated by hypothermia, such as haematological dyscrasias(including oral anticoagulant treatment with INR >=1.7 or a platelet count < 100.10exp9/L), severe pulmonary disease, severe heart failure (defined as a NYHA score of III or IV), myocardial infarction within the previous 3 months, angina pectoris in the previous three months, severe infection with a CRP > 50 mg/L, or a clinical diagnosis of sepsis;
3. Blood oxygen saturation below 92% without use of oxygen therapy or below 94 % with a maximum of 2 L/min oxygen delivered nasally;
4. Bradycardia (<40 beats/min);
5. Body weight > 120 kg;
6. Pre-stroke score on the modified Rankin Scale (mRS) > 2;
7. Allergy to pethidine or buspirone, use of a monoamine oxidase inhibitor in the previous 14 days, hepatic or severe renal dysfunction, or asthma. Severe hepatic dysfunction is defined as liver enzymes increased above two times above the upper limit of normal, and severe renal dysfunction as a glomerular filtration rate <= 30 ml/min.;
8. Pregnancy. Women of childbearing potential are excluded unless a negative test for pregnancy has been obtained prior to randomization;
9. Other serious illness that may confound treatment assessment;
10. Previous participation in this trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Feasibility, defined as the number of patients that has successfully completed<br /><br>the treatment strategy they had been assigned to.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The main secondary outcome measures include:<br /><br>1. Time to target temperature;<br /><br>2. Stability at target;<br /><br>3. Complications;<br /><br>4. Score on the modified Rankin scale at three months.</p><br>