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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02355743
Other study ID # PRO13120030
Secondary ID
Status Completed
Phase Phase 4
First received January 30, 2015
Last updated January 8, 2018
Start date February 1, 2015
Est. completion date September 3, 2016

Study information

Verified date January 2018
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary research question is, in patients with short bowel syndrome requiring central venous access device (CVAD) for long-term total parenteral nutrition, is once weekly recombinant tissue plasminogen activator (rtPA) lock therapy more effective than routine care using heparin flushes in reducing the incidence of line-associated thrombosis and infection.


Description:

Central venous access devices (CVAD) are used routinely in chronically ill pediatric patients for administration of medications, parenteral nutrition and laboratory testing. Several complications resulting from the use of long-term CVADs, namely venous sepsis and thrombosis, can significantly increase associated morbidity and mortality. CVAD-associated thrombosis occurs in up to 50% of children with long-term CVAD use and this is especially common in patients requiring life-sustaining long-term total parenteral nutrition (1). Catheter thrombosis may arise from fibrin sheath formation around the catheter tip, intraluminal blood clot within the catheter, or venous thrombosis obstructing the vein and occluding the catheter tip. Within 24 hours and typically within 2 weeks of placement of a CVAD, a fibrin sheath forms around its tip (2-5). Development of intraluminal thrombosis or venous thrombosis is less predictable.

There is a growing body of evidence linking the development of CVAD-associated thrombosis and line-related infection. It is known that proteins within the thrombus including fibronectin and fibrinogen attract bacteria, specifically staphylococcal species. The bacteria bind to ligands associated with the thrombus thus allowing for bacterial proliferation (6-8). The clinical relevance of line thrombus in development of line infection is underscored in a study of pediatric patients with Hickman catheters, of whom 18% with catheter thrombosis developed a line-associated bloodstream infection, while none developed a catheter infection that did not also have a catheter clot (7). Thus, we hypothesize that prevention of catheter-related clot formation with use of a local thrombolytic agent will also prevent infection in the catheter.

The primary research question we pose is, in patients with short bowel syndrome requiring central venous access device (CVAD) for long-term total parenteral nutrition, is once weekly recombinant tissue plasminogen activator (rtPA) lock therapy more effective than routine care using heparin flushes in reducing the incidence of line-associated thrombosis and infection.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date September 3, 2016
Est. primary completion date September 3, 2016
Accepts healthy volunteers No
Gender All
Age group 6 Months to 18 Years
Eligibility Inclusion Criteria:

1. subjects with short bowel syndrome

2. requirement for central venous access device (CVAD) for long-term TPN administration

3. age >/= 6 months to < 16 years

4. ability to initiate rtPA during hospitalization for newly inserted CVAD

5. ability to be enrolled within 48 hours of CVAD placement.

Exclusion Criteria:

1. platelet count <50,000

2. active bleeding

3. age =/> 16 years at time of consent.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
United States Children's Hospital of Pittsburgh Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Lynn Malec University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Development of CVAD Line Thrombosis 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. 24 weeks
Secondary Development of Line-associated Infection This will be defined as a line associated infection not related to other co-infection (i.e. such as pneumonia, UTI) 24 weeks
Secondary Need for Central Line Replacement This will be defined as a line removal and replacement due to infection, malfunction or other issues 24 weeks
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