Fluoxetine for motor recovery after acute intracerebral hemorrhage (FMRICH): study protocol for a randomized, double-blind, placebo-controlled, multicenter trial

Table 1 Study schedule of fluoxetine for motor recovery after acute intracerebral hemorrhage (FMRICH) clinical trial

	Screening	Visit 1	Visit 2	Visit 3
Informed consent	•
Inclusion criteria	•
Demographics^a	•
Inclusion/exclusion criteria check	•
Vital signs^b		•	•	•
Medical/drug use history^c		•
Smoking/drinking status		•
Laboratory tests^d		•
Lipid test^e		•
Coagulation tests^f		•		•
Date of bleeding		•
Condition associated with bleeding^g		•
BCT	•
Date of BCT	•
Volume of the hemorrhage^h	•
Localization of the hemorrhage	•
Concomitant medication	•	•	•	•
Adverse event			•	•
NHISS		•	•	•
Depression Scale	•		•	•
Fugl-Meyer Motor Scale	•		•	•
Patient’s rehabilitation log			•	•
Barthel Index		•	•	•
Modified Rankin Scale		•	•	•
Pill count			•	•

^aAge, gender, educational level, marital status, occupational status, date of birth, contact address and telephone number. ^bBlood pressure (mmHg), pulse (beats/minute) and body temperature (°C). ^cDiabetes Mellitus, hypertension, dyslipidemia. ^dHemoglobin, hematocrit, red blood cell count, white blood cell count, platelet count, blood urea, nitrogen/creatinine ratio, fasting plasma glucose. ^eTotal cholesterol (mg/dl), high-density lipoprotein cholesterol (mg/dl), low-density lipoprotein cholesterol (mg/dl), very low-density lipoprotein cholesterol (mg/dl), triglyceride (mg/dl). ^fInternational Normalized Ratio, prothrombin time, activated partial thromboplastic time. ^gTrauma, Drugs, bleeding disorder, exercise. ^hABC/2 method. BCT, Brain Computed Tomography; NIHSS, National Institutes of Health Stroke Scale.

ISSN: 1745-6215