A phase IIa human clinical trial will be performed to clarify the safety and efficacy of using usual dose of celecoxib (200 mg/day) for 21 days starting within 6 hours after onset of ICH. Totally 30 patients will be enrolled prospectively, and the case number was estimated by statistical methods for the percentage of participants with increased perihematomal edema volume shown in the previous clinical trial (Lee et al., 2013) (estimated by G-power software, settings as: exact test, one sample test, α = 0.05, power = 0.95). The control group will be age-, sex-, and NIHSS-matched ICH patients (n = 30) with routine treatment from the Taiwan Stroke Registry database which had been approved by the Research Ethics Committee of our hospital.~Intervention: Celecoxib 200 mg per dose, started within 6 h after onset, then one dose per day for 21 days. The low dose of Celecoxib will be used to minimize the side effect of Celecoxib. Pregnancy will be excluded at enrollment and prevented throughout the treatment period in female cases.~Evaluations:~Brain CT:~Initial brain CT: for initial hematoma volume (length * width * height /2)~Brain CT on day 2 for final hematoma volume and hematoma expansion~Brain CT on day 14, and 21 for perihematomal edema and hematoma resolution~Neurological functions: NIHSS score, GCS score, modified Rankin scale (mRS) on day 1, 2, 7, 14, 21, and mRS at 3 months~Renal function (creatinine) on day 1, 2, 7, 14 and 21~Gastrointestinal bleeding evens within 21 days~Myocardial infarction evens within 21 days~Blood sampling on day 1, 7, 14 and 21~Patient enrollment: If the patient's consciousness is not clear before the enrollment of this study, his (her) family can decide the enrollment for this patient. Once the patient regains his (her) consciousness, we will reconfirm with the patient about the enrollment of this study.~Data checks: The data recorded of this study will be double-checked for their accuracy and compared with predefined ranges to avoid typing error.~Plan for missing data: Missing data include those data which are reported as missing, unavailable, uninterpretable, or considered missing because of data inconsistency or out-of-range results. This study will try to minimize missing data by limiting the collection of data to essential information and minimizing the number of follow-up visits, develop a documentation of this study for the methods to screen the participants and the procedures to follow up, appropriate training for all personnel related to this study, and data will be reviewed as close to real-time as possible.~Statistical analysis plan: The continuous variables between Celecoxib group and control group will be compared using Mann-Whitney U test if these data are not with normal distribution, or t-test if these data are with normal distribution. Categorical data will be compared using Fisher's exact test.
This trial is a phase IIa human clinical study, in which 30 patients with intracerebral hemorrhage (ICH) at basal ganglion or thalamus within 6 h after onset will be enrolled. Early initiation of celecoxib within 6 h after ICH and treatment for 21 days will be performed. The safety will be evaluated by drug adverse effects. The efficacy will be assessed by hematoma expansion, brain edema, and 3-month modified Rankin scale.