Comparing heparin doses for surgery on brain aneurysms
Effect of Heparinization on Intracranial Aneurysm
NA · The First Affiliated Hospital with Nanjing Medical University · NCT05749393
This study is testing which dose of heparin is better for patients having surgery for brain aneurysms to see if it helps them recover more effectively.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University (other) |
| Locations | 1 site (Nanjing) |
| Trial ID | NCT05749393 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine which heparinization regimen is most beneficial for patients undergoing surgery for intracranial aneurysms. Participants will be randomly assigned to receive either 50 U/kg or 70 U/kg of intravenous heparin at one-hour intervals, with adjustments made based on specific criteria. The effectiveness of these regimens will be assessed through MRI scans performed within 72 hours post-surgery, focusing on the diffusion-weighted imaging (DWI) sequences. The study seeks to identify the optimal heparin dose that improves patient outcomes during surgical intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with confirmed unruptured intracranial aneurysms and normal coagulation function.
Not a fit: Patients with specific conditions such as dissecting aneurysms, moyamoya disease, or those who have previously used antithrombotic drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and prognosis for patients with intracranial aneurysms.
How similar studies have performed: While the specific heparinization regimens may be novel, similar studies have explored anticoagulation strategies in surgical settings, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Greater than 18 years old, less than 75 years old 2. Patients with unruptured intracranial aneurysm were confirmed by DSA. 3. Coagulation function should be normal in the enrolled patients. Exclusion Criteria: 1. Dissection aneurysm, blister aneurysm, moyamoya disease or arteriovenous malformation. 2. Previous use of antithrombotic drugs (including anticoagulant or antiplatelet aggregation drugs).
Where this trial is running
Nanjing
- Jiangsu Province Hospital — Nanjing, China (RECRUITING)
Study contacts
- Principal investigator: Hua Lu, Doctor — First Affiliated Hospital, Nanjing Medical University
- Study coordinator: Hua Lu, Doctor
- Email: luhua@njmu.edu.cn
- Phone: 18761671021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intracranial Aneurysm