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| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Zhejiang University | OTHER |
| Wuhan University | OTHER |
| Qilu Hospital of Shandong University |
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This is a randomized, open label, multi-center, positive-controlled study, in which a total of 236 patients will be enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during coil embolization in patients with ruptured intracranial aneurysms.
Procedure-related complication, mRS, Activated Clotting Time, ischemic and hemorrhagic complications, symptomatic and asymptomatic intracranial hemorrhage, death, Heparin Induced Thrombocytopenia will be evaluated during procedure, at 24hs, 7days and 30 days after.
Endovascular embolization has become an effective modality for the treatment of intracranial aneurysms. Despite advances in technology and techniques, thromboembolic and bleeding events are still encountered as inherent perioperative complications. Hypercoagulability as a systemic response to acute subarachnoid hemorrhage (SAH) may be associated with an increased incidence of thromboembolic events.
The administration of anticoagulant may reduce thromboembolic events during the endovascular embolization, meanwhile, involves the risk of bleeding. Although heparin is commonly used during the procedure, the safety in patients with ruptured intracranial aneurysms has not been established. In contrast to heparin, bivalirudin is a short-lived direct thrombin inhibitor with an intrinsic antiplatelet activity and more stable pharmacokinetic and pharmacodynamic properties which has been associated with reduced bleeding and an overall favorable profile. Bivalirudin administration in patients with high bleeding risk during coronary intervention is recommended by current guidelines.
This is an open label, multicenter, randomized pilot study, which is aimed to investigate the safety and efficacy of bivalirudin coil embolization in patients with ruptured intracranial aneurysms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bivalirudin | Experimental | Bivalirudin at full dose Bivalirudin 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until end of the procedure |
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| Heparin | Active Comparator | Heparin first dose at 0.6mg/kg(75U/kg) Heparin should be administered each hour, 0.6mg/kg(75U/kg) as bolus dose, 0.3mg/kg 1h later, 10mg(1250U) every hour after. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalirudin 250 MG Injection | Drug | Bivalirudin 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until end of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-related complication | A composite of of death from any cause, thromboembolic events, or bleeding defined by BARC definition 3 or 5 BARC=Bleeding Academic Research Consortium | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale (mRS) | The mRS score, and proportion of subjects achieving mRS score of 0-2 | 30 days |
| Activated Clotting Time (ACT) | ACT values of 0 min and 5 min after bolus injection will be recorded in all patients Extra ACT values of 15 min, 30 min, 55min, 65 min,and 115 min after bolus injection will be recorded in 8 patients of both arm, and the curve will be simulated |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Zhao, Doctor | Contact | +86-13916728169 | z_ray1979@126.com | |
| Qiao Zuo, Doctor | Contact | +86-13621817430 | dr_zuo@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianmin Liu, M.D. | Neurosurgical Department of Changhai Hospital | Principal Investigator |
| Sheng Guan, M.D. | Neurointerventional Department, The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C074619 | bivalirudin |
| D007267 | Injections |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D006025 | Glycosaminoglycans |
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| OTHER |
| The First People's Hospital of Changzhou | OTHER |
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| Heparin | Drug | Heparin should be administered each hour, 0.6mg/kg(75U/kg) as bolus dose, 0.3mg/kg 1h later, 10mg(1250U) every hour after. |
|
| During procedure |
| Procedure-related complication | A composite of of death from any cause, thromboembolic events, or bleeding defined by BARC definition 3 or 5 BARC=Bleeding Academic Research Consortium | During procedure, at 24hs, 7days |
| Thromboembolic events | Definition:
| During procedure, at 24hs, 7days, 30days |
| Bleeding events | Any bleeding as defined by the BARC definition (except grade 4) Any bleeding as defined by the GUSTO definition | During procedure, at 24hs, 7days, 30days |
| Intracranial hemorrhage | Intracranial hemorrhage and Symptomatic intracranial hemorrhage | During procedure, at 24hs, 7days, 30days |
| Heparin-induced thrombocytopenia(HIT) | defined as a platelet count decrease ofmore than50%or more than 150 × 109/L frombaseline | 7days |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |