EODHS-IA: Effect of Different Heparinization Schemes on Prognosis of Intracranial Aneurysm

• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05749393
• Collaborator: (none)
• Enrollment: 90
• Arms: 3
• Anticipated Duration (Months): 13

Study Details

Study Description

Brief Summary

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) 60 U/kg IV at 1-h intervals reduced by half to a minimum of 1000 u/h; (iii) 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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysm	Drug: Heparin sodium	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Heparinization on Intracranial Aneurysm
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Mar 31, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low-dose group 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.	Drug: Heparin sodium; Intravenous heparin was administered during intracranial aneurysm embolization with a guide catheter and discontinued at the end of the procedure.
Experimental: Medium dose group The initial dose was 60U/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.	Drug: Heparin sodium; Intravenous heparin was administered during intracranial aneurysm embolization with a guide catheter and discontinued at the end of the procedure.
Experimental: High-dose group 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.	Drug: Heparin sodium; Intravenous heparin was administered during intracranial aneurysm embolization with a guide catheter and discontinued at the end of the procedure.

Outcome Measures

Primary Outcome Measures

1. Size of the ischemic focus [This will be evaluated within 24 hours after the procedure.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• The First Affiliated Hospital with Nanjing Medical University

Investigators

• Principal Investigator: Hua Lu, Doctor, First Affiliated Hospital, Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Lu Hua, Professor, The First Affiliated Hospital with Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT05749393
• Other Study ID Numbers: EODHS-IA
• First Posted: Mar 1, 2023
• Last Update Posted: Mar 1, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Lu Hua, Professor, The First Affiliated Hospital with Nanjing Medical University: Intracranial Aneurysm
• Additional relevant MeSH terms: Intracranial Aneurysm; Aneurysm; Heparin; Calcium heparin

Study Results

No Results Posted as of Mar 1, 2023