Safety and Efficacy Study of Ultrasonic Thrombolytic Therapy for Hemodialysis Vascular Access Thrombosis

JRCT ID: jRCTs031240333

Registered date:12/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Thrombosis in Hemodialysis Vascular Access
• Date of first enrollment: 12/09/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): One vial of sonazoid is suspended in 2 ml of the supplied water for injection and administered intravenously through a contrast catheter or introducer sheath (with the peripheral end of the target residual clot clamped using the balloon catheter used in the standard treatment). Ultrasound color Doppler irradiation of the targeted thrombus is performed from the body surface. If the targeted thrombus is still present at the end of sonazoid administration, color Doppler irradiation is continued (up to 30 minutes) because of the potential thrombolytic effect of the circulating sonazoid.

Outcome(s)

Primary Outcome

1) Primary safety endpoint: nature and severity of adverse events and frequency of occurrence
2) Primary efficacy endpoint: technical success (disappearance of clots)

Secondary Outcome

1) Thrombus reduction rate (thrombus area before ultrasound irradiation - thrombus area after ultrasound irradiation)/thrombus area before ultrasound irradiation x 100)
2) Blood flow at 1 week, 1, 3, and 6 months
3) Resistance coefficient at 1 week, 1, 3, and 6 months
4) Restenosis rate at ultrasound irradiated area at 1 week, 1, 3, and 6 months (short diameter of normal vessel - short diameter of vessel at maximal stenosis / short diameter of normal vessel x 100)
5) Time to re-treatment up to 6 months

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1) Thrombotic occlusion of a dialysis vascular access (within 2 days of onset)
2) Thrombotic stenosis of the vascular access for dialysis
3) Resident in Japan, Japanese (excluding half or quarter Japanese)
4) Age between 18 and 85 years old at the time of consent
5) Have received a thorough explanation of the study and have given written consent of their own free will based on a thorough understanding of the study.
6) Patients who are able to make outpatient visits in accordance with the research schedule.
Criteria 1) and 2) are acceptable if either of the selection criteria is met.

Exclude criteria

1) Patients who have had a thrombotic occlusion for more than 3 days.
2) Patients with arteriovenous (right-left) shunts in the heart or lungs.
3) Patients with serious cardiac disease
4) Patients with serious pulmonary disease
5) Allergy to egg yolk or Sonazoid.
6) Pregnant or possibly pregnant
7) Are breast-feeding.
8) Any other person who is deemed inappropriate to participate in this study by the principal investigator (subinvestigator).

Related Information

• Primary Sponsor: Ohki Takao
• Secondary Sponsor: Shirakawa Takako
• Source(s) of Monetary Support: Grants-in-Aid for Scientific Research(JSPS)