Perioperative antihypertensive treatment in patients of spontaneous intracerebral hemorrhage (PATICH): A clinical trial protocol.

Rationale The management of perioperative period for patients with spontaneous intracerebral hemorrhage affects the prognosis. Elevated blood pressure is common in the patients with spontaneous intracerebral hemorrhage and related to a poor outcome. However, study on antihypertensive treatment for surgical patients with spontaneous intracerebral hemorrhage is insufficient. Aims To determine if the intensive antihypertensive treatment improves the prognosis compared with the conservative antihypertensive treatment followed guidelines in perioperative period for patients with spontaneous intracerebral hemorrhage. Design PATICH is a prospective, parallel, randomized, assessor-blinded trial. Two hundred eligible patients will be assigned to the intensive group and conservative group randomly. Patients allocated to the intensive group will receive an intensive antihypertensive treatment aiming to achieve a target systolic blood pressure of between 120 mm Hg and 140 mm Hg while the patients in the conservative group will receive conservative antihypertensive treatment as recommended by guidelines for 7 days. Operation will be conducted by well-trained surgeons and the best medical treatment will be given in all patients. Patients will be followed up at 7 days, 30 days, and 90 days. Study outcomes Primary outcome of this study is the rate of rehemorrhage in 7 days after surgery. Secondary outcomes include death and dependency at 90 days incidence of ischemic stroke, separate rate of death and dependency at 90 days, health related quality of life (HRQoL) at 90 days, incidence of other vascular events, and days of hospitalization. Dependency is defined by a score of 3–5 based on the modified Rankin Scale (mRS). [ABSTRACT FROM AUTHOR]