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Recruiting

NCT Number: NCT07166146

Timing and Outcomes of Recovery After intraCerebral Hemorrhage

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, China

Location status: Recruiting

Location contact

Ethics Committee of Xuanwu Hospital, Capital Medical Universit

CONTACT

[email protected]

010-83199270

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical interventions

Other

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 outcomes

  1. Functional Outcome

    Time frame: 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 outcomes

  1. Functional Outcome

    Time frame: 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

  2. Safety - Procedure -Related Mortality

    Time frame: 30 days after onset

    Safety will be assessed by determining procedure-related mortality by comparing rates of mortality at 30 days

  3. EQ-5D-5L

    Time frame: 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

  4. Functional Status in Daily Life

    Time frame: 6 months after onset

    180±14 days of Barthel index

Study contacts

Contact information is provided by the study sponsor or research team.

Tao Hong, MD

CONTACT

[email protected]

+86-13810000653

Ye Li, MD

CONTACT

[email protected]

+86-13811427057

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Acronym: TORCH

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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