Intracerebral Haemorrhage, Intracerebral Hemorrhage
Conditions
Keywords
Intracerebral Haemorrhage, Intracerebral Hemorrhage
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.
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.
Sponsors
Xuanwu Hospital, Beijing
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Backup ContactYe Li, MD
Primary ContactTao Hong, MD
Outcome results
None listed