Timing and Outcomes of Recovery After intraCerebral Hemorrhage

NCT ID: NCT07166146

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-04
• Study Completion Date: 2028-03-15

Brief Summary

The TORCH registry is a prospective, observational cohort study, which will collect detailed, longitudinal data on the clinical characteristics, treatment modalities, and outcomes of patients with ICH. By leveraging a wide array of surgical interventions - including endoscopic surgery, minimally invasive surgery combined with urokinase, and craniotomy - the TORCH registry intends to provide a granular view of early hematoma evacuation surgical interventions and their impact on patient recovery and quality of life.

Conditions

Intracerebral Haemorrhage; Intracerebral Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Surgical interventions

By leveraging a wide array of surgical interventions - including endoscopic surgery, minimally invasive surgery combined with urokinase, and craniotomy - the TORCH registry intends to provide a granular view of early hematoma evacuation surgical interventions and their impact on patient recovery and quality of life.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subject Age is ≥18 to ≤80 years
• Subject with a Head CT/CTA that demonstrates an acute, spontaneous, primary, supratentorial ICH, assessed via standard of care techniques
• Subject recieving a surgery intervention
• Subject has a NIHSS score ≥ 6 or GCS score 5≤GCS≤15
• Subject has a baseline Modified Rankin Scale (mRS) Score ≤ 1

Exclusion Criteria

• Secondary intracerebral hemorrhage (with leading cause, e.g., Moyamoya disease, arteriovenous malformation, intracranial aneurysm, tumor, brain trauma)
• Pre-stroke life expectancy < 1 year for severe comorbidities (e.g., Progressive malignant tumor, severe chronic heart failure [NYHA: III-IV], severe chronic obstructive pulmonary disease [III-IV], chronic kidney disease requiring hemodialysis)
• Patients with platelet count < 100,000, INR > 1.4, or an elevated PT or APTT (reversal of coumadin is permitted but the patient must not require coumadin during the acute hospitalization). Irreversible coagulopathy either due to medical condition or prior to randomization
• Pregnant (positive pregnancy test) or lactating females (likelihood of altered coagulation function associated with the high estrogen/progesterone state)
• Irreversibly impaired brainstem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS less than or equal to 4

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Department of Neurosurgery, China International Neuroscience Institute, Xuanwu Hospital, Capital Medical University,

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Tao Hong, MD

Role: CONTACT

hongtao.edu@gmail.com

+86-13810000653

Ye Li, MD

Role: CONTACT

yli@xwhosp.org

+86-13811427057

Facility Contacts

Ethics Committee of Xuanwu Hospital, Capital Medical Universit

Role: primary

xwkyll@xwh.ccmu.edu.cn

010-83199270

Other Identifiers

Hongtao TORCH

Identifier Type: -

Identifier Source: org_study_id