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The goal of this clinical trial is to compare intracranial aneurysm patients. The main question it aims to answer are: Which heparinization regimen is most beneficial to patients during surgery for intracranial aneurysms. Participants will be randomized to different intraoperative heparinization regimens: (i) 50 U/kg intravenous (IV) at 1-h intervals reduced by half to a minimum of 1000 u/h; (ii) 70 U/kg IV at 1-h intervals reduced by half to a minimum of 1000 u/h. MRI will be performed within 72 h after surgery, and the DWI sequence of MRI will be analyzed. If there is a comparison group: Researchers will compare different intraoperative heparinization protocol groups to see which dose of intraoperative heparin has the best prognosis for use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose group | Experimental | The initial dose was 50U/kg intravenous injection, and the dosage was halved by intravenous injection every 1 hour to the minimum 1000u/h. The medication will be discontinued at the end of the procedure. |
|
| High-dose group | Experimental | The initial dose was 70U/kg intravenous injection, and the dosage was halved by intravenous injection every 1 hour to the minimum 1000u/h. The medication will be discontinued at the end of the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin sodium | Drug | Intravenous heparin was administered during intracranial aneurysm embolization with a guide catheter and discontinued at the end of the procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Size of the ischemic focus | Cranial MRI will be performed on postoperative patients within 24 hours. The presence of high signal on diffusion weighted imaging sequences indicated the occurrence of cerebral infarction. | This will be evaluated within 24 hours after the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Lu, Doctor | Contact | 18761671021 | luhua@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hua Lu, Doctor | First Affiliated Hospital, Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Hospital | Recruiting | Nanjing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33424758 | Background | Zhang L, Zhou X, Liu Y, Ding C, Wang Y, Yang H. The Utility of Diffusion-Weighted MRI Lesions to Compare the Effects of Different Heparinization Schemes in Intracranial Aneurysms Treated by Endovascular Intervention. Front Neurol. 2020 Dec 10;11:609384. doi: 10.3389/fneur.2020.609384. eCollection 2020. | |
| 29490066 | Background |
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Individual participant data (IPD) will be available to other researchers under the approval of the ethical committee.
the data will be available when summary data are published.
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Narata AP, Amelot A, Bibi R, Herbreteau D, Angoulvant D, Gruel Y, Janot K. Dual Antiplatelet Therapy Combining Aspirin and Ticagrelor for Intracranial Stenting Procedures: A Retrospective Single Center Study of 154 Consecutive Patients With Unruptured Aneurysms. Neurosurgery. 2019 Jan 1;84(1):77-83. doi: 10.1093/neuros/nyy002. |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |