Clinical trial NCT05548530: Prognostic Analysis of Different Treatment Options for Cerebral Hemorrhage
Official title: Analysis of Related Factors of Hematoma Morphology in Patients With Cerebral Hemorrhage and Prognosis Analysis of Different Regimens for Cerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Hemorrhage
Lead sponsor: The Affiliated Hospital Of Guizhou Medical University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The inpatients admitted to the Emergency Neurology Department of the Affiliated Hospital of Guizhou Medical University from January 1, 2014 to August 31, 2022 were collected. According to the head CT at the time of admission, they were divided into the hematoma rule group and the hematoma irregular group

Brief summary: To analyze the influence of early hematoma morphology on hematoma expansion, optimize the treatment plan for cerebral hemorrhage, and guide the treatment of patients with cerebral hemorrhage in combination with clinical practice.

Detailed description: Intracerebral hemorrhage refers to the hemorrhage caused by the rupture of blood vessels in the non-traumatic brain parenchyma, accounting for 20% to 30% of all strokes, with an acute mortality rate of 30% to 40%. Different degrees of movement disorders, language disorders, etc. will be left behind. It is of great clinical significance to deeply explore the relevant factors and effective treatment plans for the evolution of cerebral hemorrhage. 30% of hematomas can still have active bleeding within 20 hours of onset. The INTERACT test defines hematoma expansion as 24-48 hours of repeated non-enhanced CT. The increase in hematoma volume \>12.5ml or 33% of the original volume is the cause of neurological deterioration and abnormality. An important cause of poor prognosis, studies have confirmed that irregular hematoma morphology is a strong predictor of hematoma expansion. Treatment of cerebral hemorrhage currently includes medical treatment and surgical treatment. Surgical treatment has become an important method for the treatment of ICH due to its advantages of rapid removal of hematoma, relief of high intracranial pressure, and release of mechanical compression. However, whether surgery can reduce the mortality of patients with cerebral hemorrhage and improve neurological damage is still controversial. Surgical operations include dstereotactic intracranial hematoma puncture and drainage, decompressive craniectomy , neuroendoscopic. Currently, there are large randomized controlled trials at home and abroad on minimally invasive hematoma evacuation. The treatment of spontaneous intracerebral hemorrhage is safe, but the effectiveness of minimally invasive surgery is unclear due to inconsistent bleeding volume, surgical trauma, and hematoma morphology.

Eligibility criteria: Inclusion Criteria:

1. Age 18-80 years old;
2. Intracerebral hemorrhage was diagnosed by head CT examination;

Exclusion Criteria:

1. Multiple intracranial hemorrhage;
2. Intracranial hemorrhage caused by intracranial tumor, aneurysm, trauma, infarction or other lesions;
3. Coagulation disorders or a history of taking anticoagulants;
4. Infectious meningitis, systemic infection;
5. History of severe stroke, heart, kidney, liver and lung dysfunction in the past;
6. Severe brain herniation (mydriasis, respiratory and circulatory failure);
7. Incomplete or missing basic data or follow-up information in the hospital.

Primary outcomes:
measure: Hematoma expansion rate 24 hours after onset
timeFrame: 24 hours of onset
measure: 90-day Modified Rankin Rating Scale score;
timeFrame: 90-day
Secondary outcomes:
measure: 90-day mortality
timeFrame: 90-day
Other outcomes:
Locations:
city: Guiyang
country: China
facility: Guizhou Medical University Affiliated Hospital
state: Guizhou
Study officials:
References: