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

April 23, 2023 updated by: Lu Hua

Reduction of Microembolism After Stent-Assisted Coil Embolization of Unruptured Intracranial Aneurysms by Administration of Tirofiban：A Randomized, Controlled, Double-blind Trial

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Nanjing, China
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The intervention group
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.
Drug: Tirofiban
Intravenous administration of tirofiban
Active Comparator: The control group
The same dose of normal saline was used instead of tirofiban.
Drug: normal saline
Intravenous administration of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microembolism
Time Frame: Within 72 hours after surgery
Number of microembolism
Within 72 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of microembolism
Time Frame: Within 48 hours after surgery
The incidence of microembolism
Within 48 hours after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemorrhage
Time Frame: Within 48 hours after surgery
The incidence of Hemorrhage
Within 48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lu Hua

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 25, 2023

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

April 21, 2023

First Submitted That Met QC Criteria

April 23, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANHSI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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