Health TrialsbyHealthPanel

Timing and Outcomes of Recovery After intraCerebral Hemorrhage

ConditionsIntracerebral HaemorrhageIntracerebral Hemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorXuanwu Hospital, Beijing

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

500

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Surgical interventions

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

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

Time frame
6 months after onset

Secondary 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

Time frame
3 months after onset
2

Safety - Procedure -Related Mortality

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

Time frame
30 days after onset
3

EQ-5D-5L

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

Time frame
6 months after onset
4

Functional Status in Daily Life

180±14 days of Barthel index

Time frame
6 months after onset

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuanwu Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov
Apply now