Evaluation of the efficacy of Intraventricular injection Actilyse(rt-PA) on recovery of patients with Spontaneous Intraventricular Hemorrhage ( IVH )
Design
In this double-blind clinical trial study (physician and patient), 40 patients with spontaneous IVH will be randomly divided into two separate groups by designing a parallel trial by considering the high inclusion and exclusion criteria and hospitalization in the neurosurgery ward of Poursina Hospital in Rasht. Took. 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 Actylase.
Settings and conduct
Forty patients with spontaneous IVH admitted to Poursina Hospital in Rasht will be randomly divided into two separate groups. The groups will include 20 patients receiving placebo and 20 patients receiving rt-PA Actylase. In the group receiving the drug for the patient 2 mg in 2 ml rt-PA every 12 hours and in the placebo group 2 ml normal saline every 12 hours It will be injected into the ventricular space via external ventricular drainage(EVD) . During the days of drug injection, CT scans of the brain are performed daily to monitor asymptomatic bleeding and measure clot status. The medication is continued every 12 hours for up to 4 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Patients with diagnosis of spontaneous IVH
Patients with diagnosis of spontaneous IVH and deep ICH with a volume of less than 20 cc
No entry criteria
All contraindications to the use of anticoagulants…..
Intervention groups
The groups will include 20 patients receiving placebo and 20 patients receiving rt-PA Actylase.
Main outcome variables
Glasgow Coma Scale, Glasgow Outcome Scale، spread of cerebral hematoma, bleeding, hydrocephalus, ventriculitis and brain infection .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200729048251N1
Registration date:2020-08-26, 1399/06/05
Registration timing:registered_while_recruiting
Last update:2020-08-26, 1399/06/05
Update count:0
Registration date
2020-08-26, 1399/06/05
Registrant information
Name
babak alijani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3333 1529
Email address
enayatbijani4@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Intraventricular injection Actilyse(rt-PA) on recovery of patients with Spontaneous Intraventricular Hemorrhage ( IVH )
Public title
Evaluation of the efficacy of Intraventricular injection Actilyse(rt-PA) on recovery of patients with Spontaneous Intraventricular Hemorrhage ( IVH )
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diagnosis of spontaneous IVH
Patients with diagnosis of spontaneous IVH and deep ICH with a volume of less than 20 cc
Exclusion criteria:
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
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Rasht - Namjoo St. - Shahid Siadati St. - Opposite to 17 Shahrivar Hospital - Old Building of the Faculty of Health - Vice Chancellor for Research and Technology
During hospitalization up to four months after discharge
Method of measurement
with determining GCS and GOS
Secondary outcomes
1
Description
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.
2
Description
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.
3
Description
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.
4
Description
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.
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Enayat Bijani
Street address
Department of Neurosurgery,Poursina Hospital, Parstar St., Farhang Square, Rasht , Postal Code 13194-41937
City
Rasht
Province
Guilan
Postal code
کد پستی 13194-41937
Phone
+98 13 3333 1529
Fax
+98 13 3333 9842
Email
enayatbijani4@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Naghipour
Street address
Rasht - Namjoo St. - Shahid Siadati St. - Opposite to 17 Shahrivar Hospital - Vice Chancellor for Research and Technology