Seems is NOT GOOD ENOUGH! Create research robust enough to create protocols from! I'd have you all fired.
Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial
- et al.
Published:April 05, 2008DOI:https://doi.org/10.1016/S1474-4422(08)70069-3
Summary
Background
There is much uncertainty about the effects of early lowering of elevated blood pressure
(BP) after acute intracerebral haemorrhage (ICH). Our aim was to assess the safety
and efficiency of this treatment, as a run-in phase to a larger trial.
Methods
Patients who had acute spontaneous ICH diagnosed by CT within 6 h of onset, elevated
systolic BP (150–220 mm Hg), and no definite indication or contraindication to treatment
were randomly assigned to early intensive lowering of BP (target systolic BP 140 mm Hg;
n=203) or standard guideline-based management of BP (target systolic BP 180 mm Hg;
n=201). The primary efficacy endpoint was proportional change in haematoma volume
at 24 h; secondary efficacy outcomes included other measurements of haematoma volume.
Safety and clinical outcomes were assessed for up to 90 days. Analysis was by intention
to treat. This trial is registered with ClinicalTrials.gov, number NCT00226096.
Findings
Baseline characteristics of patients were similar between groups, but mean haematoma
volumes were smaller in the guideline group (12·7 mL, SD 11·6) than in the intensive
group (14·2 mL, SD 14·5). From randomisation to 1 h, mean systolic BP was 153 mm Hg
in the intensive group and 167 mm Hg in the guideline group (difference 13·3 mm Hg,
95% CI 8·9–17·6 mm Hg; p<0·0001); from 1 h to 24 h, BP was 146 mm Hg in the intensive
group and 157 mm Hg in the guideline group (10·8 mm Hg, 95% CI 7·7–13·9 mm Hg; p<0·0001).
Mean proportional haematoma growth was 36·3% in the guideline group and 13·7% in the
intensive group (difference 22·6%, 95% CI 0·6–44·5%; p=0·04) at 24 h. After adjustment
for initial haematoma volume and time from onset to CT, median haematoma growth differed
between the groups with p=0·06; the absolute difference in volume between groups was
1·7 mL (95% CI −0·5 to 3·9, p=0·13). Relative risk of haematoma growth ≥33% or ≥12·5
mL was 36% lower (95% CI 0–59%, p=0·05) in the intensive group than in the guideline
group. The absolute risk reduction was 8% (95% CI −1·0 to 17%, p=0·05). Intensive
BP-lowering treatment did not alter the risks of adverse events or secondary clinical
outcomes at 90 days.
Interpretation
Early intensive BP-lowering treatment is clinically feasible, well tolerated, and
seems to reduce haematoma growth in ICH. A large randomised trial is needed to define
the effects on clinical outcomes across a broad range of patients with ICH.
Funding
National Health and Medical Research Council of Australia.
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