Trial record 14 of 29 for:    Open Studies | "Malabsorption Syndromes" | United States

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Lynn Malec, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02355743
First received: January 30, 2015
Last updated: December 18, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Short Bowel Syndrome
Drug: rtPA lock therapy
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prophylactic Recombinant Tissue Plasminogen Activator in the Prevention of Central Venous Access Device (CVAD)-Associated Thrombosis and Infection in Pediatric Patients With Short Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Development of CVAD line thrombosis [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: February 2015
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rtPA lock therapy Recipients
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
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.
Other Name: rtPA

Detailed 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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02355743

Contacts
Contact: Lynn Malec, MD lynn.malec@chp.edu

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Lynn Malec, MD University of Pittsburgh
  More Information

Responsible Party: Lynn Malec, Assistant Professor of Medicine and Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02355743     History of Changes
Other Study ID Numbers: PRO13120030 
Study First Received: January 30, 2015
Last Updated: December 18, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Malabsorption Syndromes
Syndrome
Thrombosis
Short Bowel Syndrome
Disease
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2016