Fast track — ArticlesIntensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial
Introduction
Intracerebral haemorrhage (ICH) is estimated to affect over 1 million people worldwide each year,1, 2 most of whom either die or are left seriously disabled.1, 2, 3 Early elevation of blood pressure is very common after ICH and is associated with poor outcome,4, 5, 6, 7, 8, 9, 10 and several non-randomised studies11, 12, 13 suggest that early lowering of blood pressure is beneficial in hypertensive patients with ICH. Clinical guidelines for the early management of blood pressure in ICH highlight the need for a definitive study, because recommendations are based primarily on expert opinion with no evidence from randomised trials to define either when treatment should be initiated or the extent to which blood pressure should be lowered.14, 15, 16 We report the results of the first phase of the intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT). This phase was done to establish the feasibility of early intensive lowering of blood pressure in ICH and to define effects on haematoma growth and key safety parameters. We intended to follow this run-in phase with the main phase of INTERACT, with several thousand patients; however, the executive committee decided in February, 2007, to close the run-in study after follow-up of the required number of patients, which was completed in August, 2007, because recruitment of patients was more rapid than expected and the required number was enrolled before funding was secured for the main phase.
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Participants
This investigator-initiated, multicentre, open, blinded outcome, randomised trial enrolled patients from 44 hospital sites in Australia, China, and South Korea. Eligible patients were at least 18 years of age, had spontaneous ICH confirmed by CT and elevated systolic blood pressure (≥2 measurements of 150–220 mm Hg, recorded ≥2 min apart), and were able to commence the randomly assigned treatment within 6 h of ICH onset in a suitably monitored environment. Patients were excluded for the
Results
Between November, 2005, and April, 2007, 2415 patients with suspected ICH were screened and 17% were randomly assigned to receive early intensive treatment or guideline-based treatment to lower blood pressure (figure 1). Baseline demographic and clinical characteristics and the median time from ICH onset to randomisation (about 3·5 h) were similar in the treatment groups (table 1). The proportion of patients who received any treatment to lower blood pressure in the first 24 h after ICH onset
Discussion
In this trial of patients who presented early after the onset of ICH, a management strategy of rapid lowering of blood pressure was applied in routine clinical practice with reasonable efficiency and with careful safety monitoring of patients. Additionally, this treatment seems to attenuate the growth of ICH when compared with a more conservative policy of blood pressure management that was based on a widely used guideline. Because haematoma growth is a strong predictor of morbidity and
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