Prognostic Analysis of Different Treatment Options for Cerebral Hemorrhage

Sponsor
The Affiliated Hospital Of Guizhou Medical University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05548530
Collaborator
(none)
500
115.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Stereotactic intracranial hematoma puncture

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 decompressive craniectomy and minimally invasive surgery. 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
Actual Enrollment :
500 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Analysis of Related Factors of Hematoma Morphology in Patients With Cerebral Hemorrhage and Prognosis Analysis of Different Regimens for Cerebral Hemorrhage
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Stereotactic intracranial hematoma puncture treatment group

Check the CT slice of the patient's brain, find out the patient's largest hematoma level, measure the coordinates of the puncture center, locate and mark the skull surface according to the measured coordinates, select the puncture point under the stereotaxic instrument, Mainly avoid important blood vessels, nerves and functional areas. Use an electric drill to drill the puncture needle into the center of the hematoma, and slowly aspirate the hematoma from the side hole until the suction stops when there is resistance. The residual hematoma in CT and the location of the drainage tube were determined, and the position of the puncture needle was adjusted for the situation of brain CT. After the operation, according to the re-examination of cranial CT, urokinase was injected into the hematoma cavity through the drainage tube to dissolve the residual hematoma, and the operation process strictly followed aseptic operation.

Procedure: Stereotactic intracranial hematoma puncture
Check the CT scan of the patient's brain, find out the largest hematoma level of the patient, measure the coordinates of the puncture center, locate and mark the skull surface according to the coordinates obtained from the measurement, select the puncture point under the stereotaxic instrument, and mainly avoid important blood vessels , nerves and functional areas. Use an electric drill to drill the puncture needle into the center of the hematoma, and slowly aspirate the hematoma from the side hole until the suction stops when there is resistance. The residual hematoma in CT and the location of the drainage tube were determined, and the position of the puncture needle was adjusted for the situation of brain CT. After the operation, according to the re-examination of cranial CT, urokinase was injected into the hematoma cavity through the drainage tube to dissolve the residual hematoma, and the operation process strictly followed aseptic operation.

drug treatment group

General treatment: Based on high-level nursing care and close and continuous attention to the patient's vital signs, the patient is instructed to stay in bed continuously, give oxygen, and instruct the patient to avoid emotional agitation, etc. ②Special treatment: use hemostatic drugs, control blood pressure to prevent rebleeding, control blood sugar, control body temperature, anti-epilepsy, prevent infection, dehydration and lower intracranial pressure, etc. Multisystem complications such as tract hemorrhage should be actively managed.

Outcome Measures

Primary Outcome Measures

  1. Hematoma expansion rate 24 hours after onset [24 hours of onset]

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

  2. 90-day Modified Rankin Rating Scale score; [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.

Secondary Outcome Measures

  1. 90-day mortality [90-day]

    Proportion of patients who died 90 days after discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The Affiliated Hospital Of Guizhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Zhaoxu,MD, Principal Investigator, The Affiliated Hospital Of Guizhou Medical University
ClinicalTrials.gov Identifier:
NCT05548530
Other Study ID Numbers:
  • JZSJK0828
First Posted:
Sep 21, 2022
Last Update Posted:
Sep 27, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 27, 2022