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rtPA in in the Prevention of CVAD-Associated Thrombosis and Infection in Pediatric Patients With Short Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT02355743
Recruitment Status : Completed
First Posted : February 4, 2015
Results First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Lynn Malec, University of Pittsburgh

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Short Bowel Syndrome
Intervention Drug: rtPA lock therapy
Enrollment 8
Recruitment Details Patients were recruited from the Children's Hospital of Pittsburgh of UPMC inpatient setting
Pre-assignment Details All patients received study intervention of rtPA lock therapy which was initiated within 48 hours of a new central venous access device being placed.
Arm/Group Title rtPA Lock Therapy Recipients
Hide Arm/Group Description

rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks

rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as “lock therapy” in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion.

Period Title: Overall Study
Started 8
Completed 6
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Lost to Follow-up             1
Arm/Group Title rtPA Lock Therapy Recipients
Hide Arm/Group Description

rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks

rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as “lock therapy” in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion.

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants
4.4
(1.4 to 11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
4
  50.0%
Male
4
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Hispanic or Latino
1
  12.5%
Not Hispanic or Latino
7
  87.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  12.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  25.0%
White
5
  62.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Central venous access device associated infections in prior 6 months  
Median (Inter-Quartile Range)
Unit of measure:  Infections
Number Analyzed 8 participants
2
(0.8 to 2.5)
Hospitalizations in prior 6 months  
Mean (Inter-Quartile Range)
Unit of measure:  Hospitalizations
Number Analyzed 8 participants
3
(1.8 to 4.5)
Lifetime number of central venous access devices  
Median (Inter-Quartile Range)
Unit of measure:  Central venous access devices
Number Analyzed 8 participants
6.5
(3 to 14)
Central venous access devices in prior 6 months  
Median (Inter-Quartile Range)
Unit of measure:  Central venous access devices
Number Analyzed 8 participants
2
(1.8 to 3.3)
1.Primary Outcome
Title Development of CVAD Line Thrombosis
Hide Description This will be defined as a thrombosis that is discovered due to clinical findings concerning for a possible thrombosis as identified by the treating physician including, but not limited to, swelling, color change, or pain in the extremity, CVAD not providing blood return and/or being able to be flushed.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rtPA Lock Therapy Recipients
Hide Arm/Group Description:

rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks

rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as “lock therapy” in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion.

Overall Number of Participants Analyzed 6
Mean (Full Range)
Unit of Measure: thromboses
0
(0 to 0)
2.Secondary Outcome
Title Development of Line-associated Infection
Hide Description This will be defined as a line associated infection not related to other co-infection (i.e. such as pneumonia, UTI)
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rtPA Lock Therapy Recipients
Hide Arm/Group Description:

rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks

rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as “lock therapy” in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion.

Overall Number of Participants Analyzed 6
Median (Inter-Quartile Range)
Unit of Measure: infections
0.5
(0 to 1)
3.Secondary Outcome
Title Need for Central Line Replacement
Hide Description This will be defined as a line removal and replacement due to infection, malfunction or other issues
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rtPA Lock Therapy Recipients
Hide Arm/Group Description:

rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks

rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as “lock therapy” in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion.

Overall Number of Participants Analyzed 6
Median (Inter-Quartile Range)
Unit of Measure: line replacements
1
(0 to 2.3)
Time Frame Adverse event data were collected over a course of 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title rtPA Lock Therapy Recipients
Hide Arm/Group Description

rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks

rtPA lock therapy: rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as “lock therapy” in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion.

All-Cause Mortality
rtPA Lock Therapy Recipients
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
rtPA Lock Therapy Recipients
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
rtPA Lock Therapy Recipients
Affected / at Risk (%)
Total   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
Name/Title: Lynn Malec
Organization: BloodCenter of Wisconsin, Medical College of Wisconsin
Phone: 414-257-2424
Responsible Party: Lynn Malec, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02355743     History of Changes
Other Study ID Numbers: PRO13120030
First Submitted: January 30, 2015
First Posted: February 4, 2015
Results First Submitted: January 8, 2018
Results First Posted: February 6, 2018
Last Update Posted: February 6, 2018