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Clinical Trials/NCT05548530
NCT05548530RecruitingNot Applicable

Analysis of Related Factors of Hematoma Morphology in Patients With Cerebral Hemorrhage and Prognosis Analysis of Different Regimens for Cerebral Hemorrhage

The Affiliated Hospital Of Guizhou Medical University1 site in 1 country1,000 target enrollmentStarted: January 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
1,000
Locations
1
Primary Endpoint
90-day Modified Rankin Rating Scale score;

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age 18-80 years old;
  • Intracerebral hemorrhage was diagnosed by head CT examination;

Exclusion Criteria

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

Outcomes

Primary Outcomes

90-day Modified Rankin Rating Scale score;

Time Frame: 90-day

Modified Rankin Rating Scale score at 90 days after discharge,0-3 indicates good prognosis, 4-6 indicates poor prognosis, and 6 indicates death.

Hematoma expansion rate 24 hours after onset

Time Frame: 24 hours of onset

The number of cases with enlarged hematoma after re-examination of head CT after 24 hours

Secondary Outcomes

  • 90-day mortality(90-day)

Investigators

Sponsor
The Affiliated Hospital Of Guizhou Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhaoxu,MD

Principal Investigator

The Affiliated Hospital Of Guizhou Medical University

Study Sites (1)

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