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Risk Stratification and Minimally Invasive Surgery in Acute ICH Patients

NCT03862729 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1300

Last updated 2021-11-22

No results posted yet for this study

Summary

The study consists of 2 parts: the first part is to conduct a multicenter retrospective analysis of more than 1000 acute ICH patients treated by conservative observation from 33 centers in China to create a predictive model of intracerebral hemorrhage growth based on clinical, blood, genetic, imaging, and pharmacological factors; the second part is to validate the efficacy of the minimally invasive surgery, including stereotactic thrombolysis and endoscopic surgery, in 300 eligible patients with high risk of hemorrhage growth according to the first part results in a prospective multicenter cohort study.

Conditions

  • Spontaneous Intracerebral Hemorrhage

Interventions

PROCEDURE

Minimally invasive surgery

Intracranial hematoma will be removed by intraoperative stereotactic computer tomography-guided endoscopic surgery, or surgical aspiration followed by alteplase clot irrigation (1·0 mg every 8 h for up to nine doses). CTA will be performed before operation in all the patients for intraoperative navigation, and the minimally invasive surgery will be performed within 24 hours after intracerebral hemorrhage onset.

PROCEDURE

conventional treatment

Conventional treatment includes medical treatment and conventional craniotomy.

Sponsors & Collaborators

  • National Health and Family Planning Commission, P.R.China

    collaborator OTHER_GOV

  • First Affiliated Hospital of Fujian Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2022-03-30
Completion
2022-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03862729 on ClinicalTrials.gov