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Recruiting NCT07166146

Timing and Outcomes of Recovery After intraCerebral Hemorrhage

Observational Intracerebral Haemorrhage Intracerebral Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgical interventions.
Who it may be relevant to
Registry conditions: Intracerebral Haemorrhage, Intracerebral Hemorrhage. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • Functional Outcome [Time frame: 6 months after onset]
Secondary outcome measures (4)
  • Functional Outcome [Time frame: 3 months after onset]
  • Safety - Procedure -Related Mortality [Time frame: 30 days after onset]
  • EQ-5D-5L [Time frame: 6 months after onset]
  • Functional Status in Daily Life [Time frame: 6 months after onset]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The Department of Neurosurgery, China International Neuroscience Institute, Xuanwu Hospita — Beijing

Identifiers

NCT: NCT07166146 · Hongtao TORCH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗