Cerebral Ischemia | Induced Hypertension for Treatment of Delayed Cerebral Ischaemia After Aneurysmal Subarachnoid Haemorrhage
Cerebral Ischemia research study
What is the primary objective of this study?
The objective of this multi-centre, randomized controlled trial is to investigate the outcome after induced hypertension versus no induced hypertension in patients with delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (SAH), and to assess whether induced hypertension results in improved cerebral blood flow (CBF) as measured by means of perfusion-CT.
Who is eligible to participate?
Inclusion criteria for eligibility 1. Admission to one of the participating study centres. 2. Age 18 years or over. 3. SAH with an aneurysmatic bleeding pattern. Exclusion criteria for eligibility 1. Evidence of DCI after the SAH, defined as any decrease in the level of consciousness or the development of new focal neurological deficits after the onset of the SAH that is not due to increasing hydrocephalus, rebleeding of the aneurysm, epileptic seizure, septic- or metabolic encephalopathy, unless symptoms of DCI started within 3 hours. 2. Co-existing severe head injury. 3. Perimesencephalic haemorrhage (perimesencephalic bleeding pattern and no aneurysm on CT-angiography). 4. A history of a ventricular cardiac rhythm disorder, necessitating medical treatment. 5. A history of a left ventricular heart failure, necessitating medical treatment. 6. Likely transfer to another hospital, not participating in the trial, soon after treatment for the aneurysm. 7. Moribund. 8. Pregnancy. And furthermore, in selected centres where the sub study with CT perfusion will be performed: 9. Known allergy for CT-contrast agents. 10. Renal failure, defined as a serum creatinine > 150 µmol/l, because of the risk of contrast nephropathy. 11. Diabetes mellitus. Inclusion criteria for trial participation 1. Informed consent to participate in the proposed trial when DCI will develop. 2. DCI based on a decrease of at least one point on the Glasgow Coma Scale sum score unless the decrease doesn't reflect DCI as evaluated by the treating physician, and/or the development of new focal neurological deficits, diagnosed by a neurologist, neurosurgeon or intensivist. Exclusion criteria for trial participation: 1. Another cause for neurological deterioration including. 2. A symptomatic aneurysm not yet treated by coiling or clipping. 3. Severe hypertension, defined as a spontaneous MAP of 120 mmHg or more at the moment of evaluation for trial participation. 4. 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: 5. No CTP scan at time of neurological deterioration. 6. More than 3 CTP scans since admission.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Induced hypertensionBlood pressure will be raised in order to improve cerebral blood flow (CBF). In case of a low cardiac output, inotropics will be added. Induced hypertension will be continued for at least 48 hours when patients show some improvement within the first 24 hours. After 48 hours, the dose of vasopressor will be tapered daily, and resumed in case of clinical deterioration. In patients who do not show any improvement within 24 hours, induced hypertension will not be continued.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
No interventionNo induced hypertension (reference group)
Induced hypertensionPatients who are randomised to this arm will have their blood pressure raised with vasopressors and fluids. Blood pressure will be raised in order to improve cerebral blood flow (CBF). In case of a low cardiac output, inotropics will be added. Induced hypertension will be continued for at least 48 hours when patients show some improvement within the first 24 hours. After 48 hours, the dose of vasopressor will be tapered daily, and resumed in case of clinical deterioration. In patients who do not show any improvement within 24 hours, induced hypertension will not be continued.
Start Date: August 2010
Completed Date: December 10, 2015
Phase: Phase 3
Primary Outcome: The main outcome measurement will be the modified Rankin scale at 3 months after the SAH, compared between patients who were randomized to induced hypertension and patients who were randomized to no induced hypertension.
Secondary Outcome: 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
Study sponsors, principal investigator, and references
Principal Investigator: Arjen Slooter, MD, PhD
Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)