Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses

• Sponsor: Kaiser Permanente (Other)
• Overall Status: Completed
• CT.gov ID: NCT00284739
• Collaborator: Genentech, Inc. (Industry)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 19.9
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Abscess; Pelvic Abscess	Drug: Alteplase; Other: saline	Phase 2

Detailed Description

The use of fibrinolytics for the percutaneous drainage of loculated pleural effusions has been shown to reduce the catheter dwell time and to improve drainage of the effusions. Abscesses in the abdomen and pelvis are often loculated which makes percutaneous drainage difficult. We hypothesize that the infusion of alteplase via a drainage catheter into the loculated abscess collections of the abdomen and pelvis will similarly decrease catheter dwell time and improve overall abscess drainage. The direct injection of Activase into abscess cavities utilizes a very low dose of drug within a closed environment which should not be associated with any significant risk of hemorrhage. To date, there does not appear to be a significant risk of systemic hemorrhagic complications associated with the use of intracavitary thrombolytics for the drainage of abdominopelvic abscesses although only a few such studies have been reported. We hope to prove that the use alteplase for intracavitary thrombolysis improves outcomes associated with percutaneous catheter drainage of loculated abscess collections without increasing complications or costs.

The design of the trial will be as a single-center, prospective, open-label, randomized trial comparing the infusion of Activase versus saline for treatment of loculated abdominopelvic abscesses requiring percutaneous drainage. Patients with loculated abdominopelvic abscesses who are referred for percutaneous drainage will be eligible for this study. Patients will undergo standard placement of a 10-12 french percutaneous drain into their abscess cavity under computed tomography guidance. If the entire contents of the abscess cavity cannot be aspirated at the time of initial catheter placement, the abscess will be assumed to be loculated. The patient will then be randomized to have their abscess catheter irrigated twice a day with a volume of fluid approximately equal to the one-half the residual volume of the abscess. In the control group, the normal saline will be fluid instilled into the abscess cavity. The study group will receive Activase reconstituted in sterile water and then diluted to the appropriate volume with normal saline.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses
• Study Start Date: Feb 1, 2006
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alteplase Multiple Alteplase injection into the abscess collection to improve percutaneous drainage	Drug: Alteplase; 2mg or 4mg given twice daily for three days into loculated abscess; Other Names: Activase
Placebo Comparator: Saline Multiple normal saline injection into the abscess collection to improve percutaneous drainage	Other: saline; saline injection twice daily for three days

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage [30 days]

Secondary Outcome Measures

1. 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 [3 days]

   This is the percentage of participants in whom their loculated abscess completely resolve with percutaneous drainage at the time of the first followup CT performed at 3 days after start of the intervention and therefore do NOT require additional surgical intervention.

2. Duration (in Days) of Percutaneous Drainage. [Up to 30 days]

   The total number of days that the drainage catheter was left in place from the time of randomization until the time of catheter removal. The maximum duration of measurement for this outcome was up to 30 days.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.

• Age > 18 years

• Adult, non-gravid patients with loculated abdominopelvic abscesses immediately after percutaneous drainage will be eligible to participate. A loculated abscess is defined as an abscess whose contents cannot be completely drained at the time of initial catheter placement as documented on CT.

Exclusion Criteria:

• Active internal bleeding, involving intracranial and retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts

• History of stroke within 6 months

• Uncorrectable bleeding diathesis (INR > 1.3 despite therapy)

• Recent intracranial or intraspinal surgery or trauma

• Pregnancy (positive pregnancy test)

• Pancreatic abscesses

• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated

• Participation in another simultaneous medical investigation or trial

• Participation in another clinical investigation within previous 30 days of catheter placement

• Prior enrollment in the study

• Known allergy to Alteplase or any of its components

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Foundation Hospital	Honolulu	Hawaii	United States	96819

Sponsors and Collaborators

• Kaiser Permanente
• Genentech, Inc.

Investigators

• Principal Investigator: Hyo-Chun Yoon, MD, PhD, Kaiser Permanente Hawaii

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT00284739
• Other Study ID Numbers: HI-03HYoon-02
• First Posted: Feb 1, 2006
• Last Update Posted: Feb 26, 2015
• Last Verified: Feb 1, 2015

• Additional relevant MeSH terms: Abscess; Abdominal Abscess; Tissue Plasminogen Activator

Study Results

Participant Flow

Recruitment Details	Hospitalized patients with loculated abscess were enrolled
Pre-assignment Detail	All patients had undergone percutaneous drainage for abscess and loculation documented by residual fluid surrounding the catheter after initial drainage

Arm/Group Title	Alteplase	Saline
Arm/Group Description	Multiple Alteplase injection into the abscess collection to improve percutaneous drainage	Multiple normal saline injection into the abscess collection to improve percutaneous drainage
Period Title: Overall Study
STARTED	11	9
COMPLETED	11	9
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Alteplase	Saline	Total
Arm/Group Description	Multiple Alteplase injection into the abscess collection to improve percutaneous drainage	Multiple normal saline injection into the abscess collection to improve percutaneous drainage	Total of all reporting groups
Overall Participants	11	9	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 81.8%	6 66.7%	15 75%
>=65 years	2 18.2%	3 33.3%	5 25%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48 (19)	57 (20)	52 (20)
Sex: Female, Male (Count of Participants)
Female	9 81.8%	4 44.4%	13 65%
Male	2 18.2%	5 55.6%	7 35%
Region of Enrollment (participants) [Number]
United States	11 100%	9 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alteplase	Saline
Arm/Group Description	Multiple Alteplase injection into the abscess collection to improve percutaneous drainage	Multiple normal saline injection into the abscess collection to improve percutaneous drainage
Measure Participants	11	9
Number [participants]	3 27.3%	7 77.8%

2. Secondary Outcome

Title	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
Description	This is the percentage of participants in whom their loculated abscess completely resolve with percutaneous drainage at the time of the first followup CT performed at 3 days after start of the intervention and therefore do NOT require additional surgical intervention.
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alteplase	Saline
Arm/Group Description	Multiple Alteplase injection into the abscess collection to improve percutaneous drainage	Multiple normal saline injection into the abscess collection to improve percutaneous drainage
Measure Participants	11	9
Number [percentage of patients]	82	33

3. Secondary Outcome

Title	Duration (in Days) of Percutaneous Drainage.
Description	The total number of days that the drainage catheter was left in place from the time of randomization until the time of catheter removal. The maximum duration of measurement for this outcome was up to 30 days.
Time Frame	Up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alteplase	Saline
Arm/Group Description	Multiple Alteplase injection into the abscess collection to improve percutaneous drainage	Multiple normal saline injection into the abscess collection to improve percutaneous drainage
Measure Participants	11	9
Mean (95% Confidence Interval) [days]	6	11

Adverse Events

Arm/Group Title	Alteplase		Saline
Arm/Group Description	Multiple Alteplase injection into the abscess collection to improve percutaneous drainage		Multiple normal saline injection into the abscess collection to improve percutaneous drainage
All Cause Mortality
	Alteplase		Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Alteplase		Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Alteplase		Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.