Reduction of Microembolism After the Intervention Surgery of Intracranial Aneurysms by Administration of Tirofiban

Phase 4

Recruiting

• Conditions: Intracranial Aneurysm
• Interventions: Drug: normal saline; Drug: Tirofiban

• Registration Number: NCT05841147
• Lead Sponsor: Lu Hua

Brief Summary

The goal of this clinical trial is to investigate whether intravenous injection of tilofiban can reduce microembolism in patients with unruptured intracranial aneurysms after Stent-Assisted Coil Embolization.The main questions it aims to answer are:

* Is it safe to inject tirofiban intravenously during interventional treatment of intracranial aneurysms？

* What dose of tirofiban is safe and effective?

Detailed Description

We aim to reduce microembolism in patients with unruptured intracranial aneurysms after Stent-Assisted Coil Embolization.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-04-23
• Last Update Submitted: 2023-04-23
• Study Start: 2023-04-25
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03
• Primary Completion: 2023-07-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Age was between 18 and 75 years old;
• Unruptured aneurysm with surgical indications;
• Stent assisted coil embolization treatment was received ;
• The patient was willing to receive intervention treatment.

Read More

Exclusion Criteria

• Complicated with hemorrhagic cerebrovascular diseases such as cerebral vascular malformations and moyamoya disease or their medical history;
• Recent (within 1 year) bleeding symptoms such as gastrointestinal bleeding, clinically significant urinary/reproductive tract bleeding, and skin blueness;
• Dissecting aneurysm, pseudoaneurysm, and bullous aneurysm;
• A known history of coagulation disorders, platelet abnormalities, or thrombocytopenia; 5. Platelet count less than 150 × 109/L；
• A history of major surgical procedures or severe physical trauma within one month;
• Severe uncontrolled hypertension (systolic blood pressure>160mmHg and/or diastolic blood pressure>100mmHg);
• Hemorrhagic retinopathy;
• Chronic hemodialysis;
• Renal insufficiency.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The control group	normal saline	The same dose of normal saline was used instead of tirofiban.
The intervention group	Tirofiban	An intravenous bolus (6µg/kg) over a 3 min period and a maintenance dose of 0.1µg/kg/min for 18 hour were used in this group.

Primary Outcome Measures

Name	Time	Method
Microembolism	Within 72 hours after surgery	Number of microembolism

Secondary Outcome Measures

Name	Time	Method
The incidence of microembolism	Within 48 hours after surgery	The incidence of microembolism

Trial Locations

Locations (1)

Jiangsu Province Hospital; 🇨🇳 Nanjing, China