Your session is about to expire
← Back to Search
Thrombolytic Agent
Alteplase for Intra-Abdominal Abscess
Phase 2
Waitlist Available
Led By Hyo-Chun Yoon, MD, PhD
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights
All Individual Drugs Already Approved
Summary
Intracavitary injection of low dose alteplase into loculated abdominopelvic abscesses will reduce the duration of percutaneous drainage and increase the proportion of successful drainages.
Eligible Conditions
- Intra-Abdominal Abscess
- Abdominal Abscess
- Pelvic Abscess
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Duration (in Days) of Percutaneous Drainage.
Percentage of Loculated Abscesses Which Completely Resolve With Percutaneous Drainage Alone at the First Follow-up CT Scan Performed 3 Days After Initial Drain Placement
Side effects data
From 2017 Phase 4 trial • 81 Patients • NCT0215952110%
Deep vein thrombosis
8%
Nausea
6%
Procedural haemorrhage
4%
Pain in extremity
4%
Back pain
3%
Pruritus
3%
Asthma
3%
Haematoma
3%
Anaemia
3%
Bradycardia
3%
Anxiety
3%
Contusion
3%
Haematuria
1%
Hypertension
1%
Pelvic venous thrombosis
1%
Lactic acidosis
1%
Blood fibrinogen decreased
1%
Constipation
1%
Dizziness
1%
Oxygen saturation decreased
1%
Upper gastrointestinal haemorrhage
1%
Sinusitis
1%
Epistaxis
1%
Migraine
1%
Drug hypersensitivity
1%
Insomnia
1%
Atrial fibrillation
1%
Haemoptysis
1%
Joint effusion
1%
Groin pain
1%
Pneumonia aspiration
1%
Post procedural haemorrhage
1%
Oedema
1%
Injection site haemorrhage
1%
Abdominal pain
1%
Uterine haemorrhage
1%
Cardiac failure congestive
1%
Pulmonary embolism
1%
Ecchymosis
1%
Osteomyelitis
1%
Septic shock
1%
Haemorrhage
1%
Rash
1%
Venous occlusion
1%
Hypoaesthesia
1%
Dyspnoea
1%
Ventricular extrasystoles
1%
Urinary tract infection
1%
Heparin-induced thrombocytopenia
1%
Skin ulcer
1%
Dysuria
1%
Squamous cell carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
EkoSonic® Endovascular System
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AlteplaseExperimental Treatment1 Intervention
Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
Group II: SalinePlacebo Group1 Intervention
Multiple normal saline injection into the abscess collection to improve percutaneous drainage
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alteplase
FDA approved
Find a Location
Who is running the clinical trial?
Kaiser PermanenteLead Sponsor
554 Previous Clinical Trials
27,731,734 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,564 Previous Clinical Trials
570,626 Total Patients Enrolled
Hyo-Chun Yoon, MD, PhDPrincipal InvestigatorKaiser Permanente Hawaii
Share this study with friends
Copy Link
Messenger