Timing and Outcomes of Recovery After intraCerebral Hemorrhage

Recruiting

• Conditions: Intracerebral Haemorrhage; Intracerebral Hemorrhage

• Registration Number: NCT07166146
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-04
• Status Verified: 2025-09
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-10
• Primary Completion: 2027-03-15
• Study Completion: 2028-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Outcome	6 months after onset	modified Rankin Score (mRS) 0=no symptoms, 1=no significant disability, 2=slight disability, 3= moderate disability, 4=moderate severe disability, 5=severe disability, 6=death

Secondary Outcome Measures

Name	Time	Method
Functional Outcome	3 months after onset	modified Rankin Score (mRS) 0=no symptoms, 1=no significant disability, 2=slight disability, 3= moderate disability, 4=moderate severe disability, 5=severe disability, 6=death
Safety - Procedure -Related Mortality	30 days after onset	Safety will be assessed by determining procedure-related mortality by comparing rates of mortality at 30 days
EQ-5D-5L	6 months after onset	EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L
Functional Status in Daily Life	6 months after onset	180±14 days of Barthel index

Trial Locations

Locations (1)

The Department of Neurosurgery, China International Neuroscience Institute, Xuanwu Hospital, Capital Medical University,; 🇨🇳 Beijing, China