Randomized trial to assess safety and clinical efficacy of intensive blood pressure reduction in acute spontaneous intracerebral haemorrhage.

BACKGROUND

Haematoma expansion due to raised blood pressure in spontaneous intracerebral haemorrhage may determine outcome. The aim of this study was to determine safety and efficacy of lowering blood pressure in acute spontaneous intracerebral haemorrhage.

METHODS

This open label, multicentric trial randomized patients ≥18 years with spontaneous intracerebral haemorrhage with no secondary cause within 72 h of onset to tight BP control arm where treatment was initiated if mean arterial pressure (MAP) was ≥115 mm of Hg and conventional BP control arm where treatment was initiated if MAP was ≥130 mm of Hg. The MAP was maintained in the respective arm for another 72 h after which both arms had MAP below 115 mm of Hg. Primary outcome was modified Rankin Scale at 90 days.

RESULTS

118 patients, 59 in each arm were included. Follow up was available for all. Baseline characteristics were similar. At 90 days there was no significant difference between median mRS between the two arms. Odds Ratio for "poor outcome" (mRS 3-6) in the tight control arm (safety of the intervention) against "good outcome" (mRS 0-2) was not significant (OR 0.70 [95% CI 0.34-1.47]  = 0.35). Efficacy of the intervention in the form of Odds Ratio for "good outcome" in the tight control arm was not significant (OR 1.43 [95% CI 0.68-2.99],  = 0.35).

CONCLUSION

In patients with spontaneous intracerebral haemorrhage who present within 72 h of the onset of symptoms, MAP can be safely lowered if it crosses 115 mm of Hg but it does not improve clinical outcome.