Trial Outcomes & Findings for Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses (NCT NCT00284739)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

30 days

Results posted on

2015-02-26

Participant Flow

Hospitalized patients with loculated abscess were enrolled

All patients had undergone percutaneous drainage for abscess and loculation documented by residual fluid surrounding the catheter after initial drainage

Participant milestones

Participant milestones
Measure	Alteplase Multiple Alteplase injection into the abscess collection to improve percutaneous drainage	Saline Multiple normal saline injection into the abscess collection to improve percutaneous drainage
Overall Study STARTED	11	9
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alteplase n=11 Participants Multiple Alteplase injection into the abscess collection to improve percutaneous drainage	Saline n=9 Participants Multiple normal saline injection into the abscess collection to improve percutaneous drainage	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	48 years STANDARD_DEVIATION 19 • n=5 Participants	57 years STANDARD_DEVIATION 20 • n=7 Participants	52 years STANDARD_DEVIATION 20 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Alteplase n=11 Participants Multiple Alteplase injection into the abscess collection to improve percutaneous drainage	Saline n=9 Participants Multiple normal saline injection into the abscess collection to improve percutaneous drainage
Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage	3 participants	7 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Alteplase n=11 Participants Multiple Alteplase injection into the abscess collection to improve percutaneous drainage	Saline n=9 Participants Multiple normal saline injection into the abscess collection to improve 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	82 percentage of patients	33 percentage of patients

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Alteplase n=11 Participants Multiple Alteplase injection into the abscess collection to improve percutaneous drainage	Saline n=9 Participants Multiple normal saline injection into the abscess collection to improve percutaneous drainage
Duration (in Days) of Percutaneous Drainage.	6 days Interval 4.5 to 7.5	11 days Interval 8.0 to 14.0

Adverse Events

Alteplase

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hyo-Chun Yoon, MD,PHD

Kaiser Permanente

Phone: 8084327342

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place