Prognostic Analysis of Different Treatment Options for Cerebral Hemorrhage
Analysis of Related Factors of Hematoma Morphology in Patients With Cerebral Hemorrhage and Prognosis Analysis of Different Regimens for Cerebral Hemorrhage
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 31, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
March 18, 2026
October 1, 2025
13.2 years
August 31, 2022
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Hematoma expansion rate 24 hours after onset
The number of cases with enlarged hematoma after re-examination of head CT after 24 hours
24 hours of onset
90-day Modified Rankin Rating Scale score;
Modified Rankin Rating Scale score at 90 days after discharge，0-3 indicates good prognosis, 4-6 indicates poor prognosis, and 6 indicates death.
90-day
Secondary Outcomes (1)
90-day mortality
90-day
Study Arms (4)
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.
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.
decompressive craniectomy treatment group
Prior to the procedure, all patients obtained endotracheal intubation under general anesthesia following the informed consent provided by their family members. Upon identifying the hematoma's location through CT imaging, the surgeon made a linear or horseshoe-shaped incision on the scalp and subsequently opened the dura mater after creating a bone flap. The hematoma was punctured using a brain needle, allowing for effective decompression. The cerebral cortex was incised along the cerebral gyri, facilitating the separation of brain tissue to eliminate residual hematoma. Once hemostasis was ensured within the operative area, a silicone drainage tube was inserted, and the cranial bone flap was restored to its original position. In cases of severe brain edema or cerebral herniation, bone flap decompression was performed.
Neuroendoscopic treatment group
The patient's preoperative CT and MR imaging data were fused with a neuronavigation system to avoid important functional areas and select the closest point of the hematoma to the cortex as the location point. Routine craniotomy was performed with a 2\*3 cm bone window, the puncture direction was repositioned by neuronavigation, the sheath was placed at the center of the hematoma, the core was removed, the endoscope was gradually aspirated, and the bleeding was stopped with electrocoagulation if there was considerable active bleeding. A drainage tube was placed, the bone flap was reset after surgery, and the scalp was sutured.
Interventions
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.
Prior to the procedure, all patients obtained endotracheal intubation under general anesthesia following the informed consent provided by their family members. Upon identifying the hematoma's location through CT imaging, the surgeon made a linear or horseshoe-shaped incision on the scalp and subsequently opened the dura mater after creating a bone flap. The hematoma was punctured using a brain needle, allowing for effective decompression. The cerebral cortex was incised along the cerebral gyri, facilitating the separation of brain tissue to eliminate residual hematoma. Once hemostasis was ensured within the operative area, a silicone drainage tube was inserted, and the cranial bone flap was restored to its original position. In cases of severe brain edema or cerebral herniation, bone flap decompression was performed.
The patient's preoperative CT and MR imaging data were fused with a neuronavigation system to avoid important functional areas and select the closest point of the hematoma to the cortex as the location point. Routine craniotomy was performed with a 2\*3 cm bone window, the puncture direction was repositioned by neuronavigation, the sheath was placed at the center of the hematoma, the core was removed, the endoscope was gradually aspirated, and the bleeding was stopped with electrocoagulation if there was considerable active bleeding. A drainage tube was placed, the bone flap was reset after surgery, and the scalp was sutured.
Eligibility Criteria
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
You may qualify if:
- Age 18-80 years old;
- Intracerebral hemorrhage was diagnosed by head CT examination;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guizhou Medical University Affiliated Hospital
Guiyang, Guizhou, China
Related Publications (1)
Wu Q, Chen N, Ren Y, Ren S, Ye F, Zhao X, Wu G, Wang L. Morphological characteristics of CT blend sign predict hematoma expansion and outcomes in intracerebral hemorrhage in elderly patients. Front Med (Lausanne). 2024 Oct 1;11:1442724. doi: 10.3389/fmed.2024.1442724. eCollection 2024.
PMID: 39411190DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 31, 2022
First Posted
September 21, 2022
Study Start
January 1, 2014
Primary Completion (Estimated)
March 25, 2027
Study Completion (Estimated)
January 31, 2028
Last Updated
March 18, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share