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IRCT20200729048251N1 IRCT 2020-08-26 Rasht University of Medical Sciences Evaluation of the efficacy of Intraventricular injection Actilyse(rt-PA) on recovery of patients with Spontaneous Intraventricular Hemorrhage ( IVH ) Evaluation of the efficacy of Intraventricular injection Actilyse(rt-PA) on recovery of patients with Spontaneous Intraventricular Hemorrhage ( IVH ) 2020-08-22 anticipated 40 Complete https://irct.ir/trial/50011 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study was designed considering the high mortality rate of patients with spontaneous IVH and the importance of improving these patients and the positive results of similar studies, Randomization description: To block randomization, sealed envelope software will be used, considering 6 blocks based on gender. Allocation ratio equal to one and the study groups will include 20 patients receiving placebo and 20 patients receiving rt-PA octylase. Consent is obtained from both groups to participate in this study, Blinding description: In this double-blind clinical trial study (physician and patient), 40 patients with spontaneous IVH who are randomly assigned to the neurosurgery ward of Poursina Hospital in Rasht will be randomly divided into two separate groups with Parallel trial design. Written consent has been obtained from the patient or the patient's companion to participate in the study, but no information has been given about which group to attend. Similarly, the treating physician is aware of the patient's presence but is not aware of which group to attend, and only the researcher and the person responsible for assessing the outcome are aware of the details of the drug vial or placebo injection for the patient. 3 Spontaneous Intraventricular Hemorrhage. Intervention 1: Intervention group: In this clinical trial study, 20 patients with spontaneous IVH who underwent external ventricular drainage (EVD) due to hydrocephalus symptoms and were admitted to the neurosurgery ward of Poursina Hospital in Rasht, taking into account the high inclusion and exclusion criteria. It is randomly assigned to the drug group and the patient will be injected with 2 mg in 2 ml rt-PA (octylase) every 12 hours via EVD. According to studies, the above drug dose is safe. During the days of drug injection, CT scans of the brain are performed daily to monitor asymptomatic bleeding and measure clot status. Medication is continued every 12 hours for up to 4 days. In case of severe complications (symptomatic bleeding), the drug should be stopped immediately. Serum coagulation factors and markers of infection are monitored daily in the CSF. Blood pressure, temperature are checked every 8 hours when receiving the drug. Intervention 2: Control group: 20 patients with spontaneous IVH who underwent external ventricular drainage (EVD) due to hydrocephalus symptoms and were admitted to the neurosurgery ward of Poursina Hospital in Rasht randomly in the placebo group due to high inclusion and exclusion criteria. And 2 ml of normal saline will be injected into the ventricular space every 12 hours to 4 days via EVD. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After completing the research, a decision is made on how to publish
public Enayat Bijani
Department of Neurosurgery,Poursina Hospital, Parstar St., Farhang Square, Rasht , Postal Code 13194-41937
rasht Iran (Islamic Republic of) کد پستی 13194-41937 +98 13 3333 1529 enayatbijani4@gmail.com Rasht University of Medical Sciences scientific Enayat Bijani
Department of Neurosurgery,Poursina Hospital, Parstar St., Farhang Square, Rasht , Postal Code 13194-41937
Rasht Iran (Islamic Republic of) کد پستی 13194-41937 +98 13 3333 1529 Enayatbijani4@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients with diagnosis of spontaneous IVH Patients with diagnosis of spontaneous IVH and deep ICH with a volume of less than 20 cc no limit no limit Both All contraindications to the use of anticoagulants Patients with known bleeding disorder Patients with evidence of uncontrolled hypertension Systolic pressure greater than 180 or diastolic pressure greater than 110 Patients with evidence of acute pancreatitis Patients with proven gastrointestinal ulcer disease in the last 3 months, esophageal varices, arterial aneurysms, venous arterial malformations Recent severe and dangerous bleeding Bacterial endocarditis and pericarditis Neoplasms with an increased risk of bleeding Severe liver disease such as liver failure, liver cirrhosis, increased portal vein pressure (esophageal varices) and active hepatitis Major surgery or significant trauma in the last 3 months Platelet count below 100,000 Recent extracorporeal trauma massage (less than 10 days), recent delivery, recent non-compressible vascular puncture such as subclavian or jugular vein I61.5 Nontraumatic intracerebral hemorrhage, intraventricular Treatment - Drugs Placebo Intervention group: In this clinical trial study, 20 patients with spontaneous IVH who underwent external ventricular drainage (EVD) due to hydrocephalus symptoms and were admitted to the neurosurgery ward of Poursina Hospital in Rasht, taking into account the high inclusion and exclusion criteria. It is randomly assigned to the drug group and the patient will be injected with 2 mg in 2 ml rt-PA (octylase) every 12 hours via EVD. According to studies, the above drug dose is safe. During the days of drug injection, CT scans of the brain are performed daily to monitor asymptomatic bleeding and measure clot status. Medication is continued every 12 hours for up to 4 days. In case of severe complications (symptomatic bleeding), the drug should be stopped immediately. Serum coagulation factors and markers of infection are monitored daily in the CSF. Blood pressure, temperature are checked every 8 hours when receiving the drug. Control group: 20 patients with spontaneous IVH who underwent external ventricular drainage (EVD) due to hydrocephalus symptoms and were admitted to the neurosurgery ward of Poursina Hospital in Rasht randomly in the placebo group due to high inclusion and exclusion criteria. And 2 ml of normal saline will be injected into the ventricular space every 12 hours to 4 days via EVD. Recovery of patients with determining GCS and GOS. Timepoint: During hospitalization up to four months after discharge. Method of measurement: with determining GCS and GOS. Death. Timepoint: From hospitalization to four months after discharge. Method of measurement: During the treatment process, daily follow-up of patients in case of patient death at the time of hospitalization is recorded as a case of death, and in case of patient death within four months after discharge, information is obtained from the patient's family through telephone follow-up. Cerebral hematoma volume change. Timepoint: At the time of hospitalization. Method of measurement: During the treatment process, daily follow-up of patients on the days of drug injection is performed daily CT scan of the brain to monitor asymptomatic bleeding and measure clot status. Medication is continued every 12 hours for up to 4 days. In case of severe complications (symptomatic bleeding), the drug should be stopped immediately. Brain infection. Timepoint: At the time of hospitalization. Method of measurement: During the treatment process, daily follow-up of patients and sending csf samples via evd and examination of infection markers in CSF is performed. Bleeding. Timepoint: At the time of hospitalization. Method of measurement: During the treatment process, asymptomatic bleeding is monitored by daily follow-up of patients. In case of severe complications (symptomatic bleeding), the drug should be stopped immediately. Serum coagulation factors are monitored daily. Rasht University of Medical Sciences Approved 2020-07-15 Ethics Committee of Guilan University of Medical Sciences Rasht - Namjoo St. - Shahid Siadati St. - Opposite to 17 Shahrivar Hospital - Old Building of the Faculty of Health - Vice Chancellor for Research and Technology Rasht Guilan Iran (Islamic Republic of)