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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. â‘¡Special 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic intracranial hematoma puncture | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 90-day mortality | Proportion of patients who died 90 days after discharge | 90-day |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wu guofeng, Doctor | Contact | 13809431723 | ||
| Zhao xu, Master | Contact | 18785775120 | 1684283389@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guizhou Medical University Affiliated Hospital | Recruiting | Guiyang | Guizhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41749143 | Derived | Zhao X, Ma W, Zhang W, Deng M, Wang L, Wu G, Ren S. Optimal hematoma volume cutoffs and efficacy of minimally invasive surgery for thalamic hemorrhage: a propensity score-matched analysis. BMC Neurol. 2026 Feb 27;26(1):217. doi: 10.1186/s12883-026-04748-1. | |
| 41006456 | Derived | Wu Q, Huang L, Chen N, Ren S, Ye F, Zhao X, Wu G, Wang L. Quantification of hounsfield unit difference in heterogeneous hematoma predicts poor functional outcomes in acute intracerebral hemorrhage. Sci Rep. 2025 Sep 26;15(1):33007. doi: 10.1038/s41598-025-18409-9. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2022 | Mar 26, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 9, 2022 | Mar 26, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D056424 | Decompressive Craniectomy |
| ID | Term |
|---|---|
| D019299 | Decompression, Surgical |
| D013514 | Surgical Procedures, Operative |
| D003399 | Craniotomy |
| D019635 | Neurosurgical Procedures |
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|
| 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. |
|
|
| decompressive craniectomy | Procedure | 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 | Procedure | 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. |
|
| 39411190 | Derived | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |