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Thrombolytic Agent

Alteplase for 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 30 days
Awards & highlights

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
  • Abdominal Abscess
  • Pelvic Abscess

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage
Secondary outcome measures
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 • NCT02159521
10%
Deep vein thrombosis
8%
Nausea
6%
Procedural haemorrhage
4%
Pain in extremity
4%
Back pain
3%
Haematoma
3%
Pruritus
3%
Bradycardia
3%
Anxiety
3%
Asthma
3%
Contusion
3%
Anaemia
3%
Haematuria
1%
Sinusitis
1%
Osteomyelitis
1%
Urinary tract infection
1%
Cardiac failure congestive
1%
Septic shock
1%
Oxygen saturation decreased
1%
Pneumonia aspiration
1%
Epistaxis
1%
Hypertension
1%
Joint effusion
1%
Rash
1%
Dyspnoea
1%
Pelvic venous thrombosis
1%
Injection site haemorrhage
1%
Migraine
1%
Ventricular extrasystoles
1%
Insomnia
1%
Constipation
1%
Post procedural haemorrhage
1%
Abdominal pain
1%
Ecchymosis
1%
Uterine haemorrhage
1%
Atrial fibrillation
1%
Hypoaesthesia
1%
Groin pain
1%
Dizziness
1%
Haemorrhage
1%
Upper gastrointestinal haemorrhage
1%
Heparin-induced thrombocytopenia
1%
Oedema
1%
Pulmonary embolism
1%
Lactic acidosis
1%
Haemoptysis
1%
Venous occlusion
1%
Drug hypersensitivity
1%
Blood fibrinogen decreased
1%
Skin ulcer
1%
Dysuria
1%
Squamous cell carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
EkoSonic® Endovascular System

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
542 Previous Clinical Trials
23,907,110 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,542 Previous Clinical Trials
568,057 Total Patients Enrolled
Hyo-Chun Yoon, MD, PhDPrincipal InvestigatorKaiser Permanente Hawaii
~1 spots leftby Sep 2025
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