Thrombosis in Hemodialysis Vascular Access Thrombosis in Hemodialysis Vascular Access
Conditions
Interventions
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 res
Sponsors
Ohki Takao
Shirakawa Takako
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Primary safety endpoint: nature and severity of adverse events and frequency of occurrence 2) Primary efficacy endpoint: technical success (disappearance of clots) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactKentaro Kasa
The Jikei University Hospital
Outcome results
None listed