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Randomized Controlled Trial Multicenter Study Clinical Trial
Effect of calcitonin-gene-related peptide in patients with delayed postoperative cerebral ischaemia after aneurysmal subarachnoid haemorrhage. European CGRP in Subarachnoid Haemorrhage Study Group.
- Lancet. 1992 Apr 4;339(8797):831-4.
AbstractThe finding that the carotid vascular beds are sensitive to the potent vasodilator calcitonin-gene-related peptide (CGRP) suggested that the drug might help to prevent ischaemic deterioration after surgery for aneurysmal subarachnoid haemorrhage (SAH). The results of a preliminary study were encouraging, so we have carried out a randomised multicentre single-blind comparison of CGRP and standard best management in patients with ischaemic deficits after surgery for ruptured intracranial aneurysms. Patients aged 18-70 years in whom a focal neurological deficit developed or who had a reduction of 2 or more points on the Glasgow coma scale (GCS) after surgery entered the study after computed tomography had excluded non-ischaemic causes for the neurological deficit. 62 patients were randomly assigned an infusion of 0.6 micrograms/min CGRP for 4 h, then up to a maximum of 10 days, and 55 patients standard best management (controls). GCS and haemodynamic variables were assessed during the hospital stay, and all patients were followed up at 3 months by an independent investigator, who was unaware of their treatment. Outcome, measured on the Glasgow outcome scale, at 3 months was good in 66% of those treated with CGRP and 60% in the controls; the relative risk of a poor outcome in CGRP-treated patients was 0.88 (95% confidence interval 0.60 to 1.28). Hypotension was a common side-effect of the CGRP infusion. 66% of the CGRP group did not complete treatment because of adverse events (19 patients), lack of improvement at 4 h (17 patients) or later (4 patients), or patient's request (1 patient). Although we could not show a significant beneficial effect of CGRP in this trial, the wide confidence interval for the risk of a poor outcome and the fact that only a third of patients completed treatment mean that a clinically useful benefit cannot yet be ruled out.
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