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出境医 / 临床实验 / The Role of Deep Cerebral Vein Variation in Patients With Angiographic Negative Subarachnoid Hemorrhage
The Role of Deep Cerebral Vein Variation in Patients With Angiographic Negative Subarachnoid Hemorrhage
Study Description
Brief Summary:
The incidence of Rosenthal basilar vein (BVR) variants (deep venous drainage variants) was relatively increased in patients with AN-SAH compared with patients with aneurysms. However, the inclusion criteria for AN-SAH patients in these studies were different. Some studies have investigated both PAN-SAH and NPAN-SAH, while some studies have only investigated PAN-SAH patients. However, we believe that NPAN-SAH may be the bleeding caused by non-BVR variation. Although previous studies did not find any association between NPAN-SAH and BVR variants, the results in their study were different, which may be due to the limited number of cases.
| Condition or disease | Intervention/treatment |
|---|---|
| Subarachnoid Hemorrhage, Aneurysmal | Drug: nimodipine and euvolemia |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 296 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | The Role of Deep Cerebral Vein Variation in Patients With Angiographic Negative Subarachnoid Hemorrhage |
| Actual Study Start Date : | January 2013 |
| Estimated Primary Completion Date : | January 2023 |
| Estimated Study Completion Date : | January 2023 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- favorable or poor outcome [ Time Frame: 1 year ]poor outcome (mRS 2-6) or favorable outcome (mRS 0-1).
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 18, 2021 | ||||||||
| First Posted Date | June 28, 2021 | ||||||||
| Last Update Posted Date | June 28, 2021 | ||||||||
| Actual Study Start Date | January 2013 | ||||||||
| Estimated Primary Completion Date | January 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
favorable or poor outcome [ Time Frame: 1 year ] poor outcome (mRS 2-6) or favorable outcome (mRS 0-1).
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | The Role of Deep Cerebral Vein Variation in Patients With Angiographic Negative Subarachnoid Hemorrhage | ||||||||
| Official Title | The Role of Deep Cerebral Vein Variation in Patients With Angiographic Negative Subarachnoid Hemorrhage | ||||||||
| Brief Summary | The incidence of Rosenthal basilar vein (BVR) variants (deep venous drainage variants) was relatively increased in patients with AN-SAH compared with patients with aneurysms. However, the inclusion criteria for AN-SAH patients in these studies were different. Some studies have investigated both PAN-SAH and NPAN-SAH, while some studies have only investigated PAN-SAH patients. However, we believe that NPAN-SAH may be the bleeding caused by non-BVR variation. Although previous studies did not find any association between NPAN-SAH and BVR variants, the results in their study were different, which may be due to the limited number of cases. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | This project plans to include 296 patients who meet the admission and discharge criteria | ||||||||
| Condition | Subarachnoid Hemorrhage, Aneurysmal | ||||||||
| Intervention | Drug: nimodipine and euvolemia
administered nimodipine to prevent vasospasm, and euvolemia was maintained via intravenous hydration
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| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
296 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | January 2023 | ||||||||
| Estimated Primary Completion Date | January 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria: Patients with negative subarachnoid hemorrhage diagnosed by DSA Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04941846 | ||||||||
| Other Study ID Numbers | 2020111 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||||||
| Study Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||||||
| Verification Date | June 2021 | ||||||||