Evaluation of the efficacy of Intraventricular injection Actilyse(rt-PA) on recovery of patients with Spontaneous Intraventricular Hemorrhage ( IVH )

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200729048251N1

Enrollment

Registered

2020-08-26

Start date

2020-08-22

Completion date

Unknown

Last updated

2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous Intraventricular Hemorrhage. Nontraumatic intracerebral hemorrhage, intraventricular

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.;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.	—

Measure

Time frame

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.;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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEnayat Bijani

Rasht University of Medical Sciences

enayatbijani4@gmail.com+98 13 3333 1529

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026