Multicenter prospective cohort study for the prevention and treatment of hydrocephalus after acute cerebral hemorrhage with traditional Chinese medicine

Not Applicable

• Conditions: hydrocephalus after acute cerebral hemorrhage

• Registration Number: ITMCTR1900002389
• Lead Sponsor: Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Traditional Chinese Medicine Hospital)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) The first time onset cerebral hemorrhage;
(2) Meet the diagnostic criteria for cerebral hemorrhage, and the GCS score is >4 points;
(3) Aged 40 and 75 years old;
(4) Agree to participate in the trial and sign the informed consent form.

Exclusion Criteria

(1) The patient's cerebral hemorrhage is caused by brain tumor, brain trauma, blood disease (secondary to anticoagulant and thrombolytic therapy);
(2) with a mixed stroke or cerebral hemorrhage with severe bleeding needs to surgery;
(3) The clinical manifestations of cerebral palsy, including the disappearance of ipsilateral pupillary reflexes and other third pairs of cranial nerve paralysis;
(4) with pulmonary heart disease, unstable angina or acute myocardial infarction within 6 months;
(5) with neurological deficits (mRS>2) before the onset of AICH;
(6) Accompanied by severe cardiac insufficiency (NYHA cardiac function classification III-IV);
(7) Accompanied by severe hepatic insufficiency (the liver function test results exceed 2 times the upper limit of the normal range);
(8) Accompanied by severe renal insufficiency (the serum creatinine is more than twice the upper limit of the normal range);
(9) Active gastrointestinal bleeding occurs after the onset of AICH in patients;
(10) The patient has a heavier blood system or other systemic underlying disease;
(11) The patient is in a state of pregnancy or breastfeeding, or has a severe allergic disease or is allergic to multiple drugs;
(12) The patient has other diseases that cause his neurological deficit, or join the study to aggravate his condition;
(13) The patient has participated in other clinical trials in the past 3 months;
(14) Patients without malignant tumors and receiving radiotherapy and chemotherapy

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hematoma volume;NIHSS score;The incidence of hydrocephalus after acute cerebral hemorrhage in two cohorts;Hematoma volume;

Secondary Outcome Measures

Name	Time	Method
The occurrence of death endpoints in each study cohort from the implementation of the program to the end of treatment;Quality of life indicator;