Prognostic Analysis of Different Treatment Options for Cerebral Hemorrhage

NCT ID: NCT05548530

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2025-12-31

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.

Conditions

Brain Hemorrhage

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Stereotactic intracranial hematoma puncture

Intervention Type: 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.

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.

No interventions assigned to this group

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.

decompressive craniectomy

Intervention Type: 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 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.

Neuroendoscopic

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

decompressive craniectomy

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.

Intervention Type: PROCEDURE

Neuroendoscopic

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Affiliated Hospital Of Guizhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhaoxu，MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guizhou Medical University Affiliated Hospital

Guiyang, Guizhou, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wu guofeng, Doctor

Role: CONTACT

13809431723

Zhao xu, Master

Role: CONTACT

1684283389@qq.com

18785775120

Facility Contacts

Wu guofeng, Doctor

Role: primary

13809431723

References

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.

Reference Type: DERIVED

PMID: 39411190 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

JZSJK0828

Identifier Type: -

Identifier Source: org_study_id