NCT07166146

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Jun 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Jun 2025Mar 2028

Study Start

First participant enrolled

June 4, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2028

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

September 2, 2025

Last Update Submit

September 2, 2025

Conditions

Intracerebral HaemorrhageIntracerebral Hemorrhage

Keywords

Intracerebral HaemorrhageIntracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Functional Outcome

    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

    6 months after onset

Secondary Outcomes (4)

  • Functional Outcome

    3 months after onset

  • Safety - Procedure -Related Mortality

    30 days after onset

  • EQ-5D-5L

    6 months after onset

  • Functional Status in Daily Life

    6 months after onset

Interventions

Surgical interventionsOTHER

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

500

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, China

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Tao Hong, MD

CONTACT

+86-13810000653hongtao.edu@gmail.com

Ye Li, MD

CONTACT

+86-13811427057yli@xwhosp.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 10, 2025

Study Start

June 4, 2025

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 15, 2028

Last Updated

September 10, 2025

Record last verified: 2025-09

Locations

CN(1)