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

NCT02355743 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: PRO13120030
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Development of Line-associated Infection

  24 weeks

• Need for Central Line Replacement

  24 weeks

Study Arms (1)

rtPA lock therapy Recipients

EXPERIMENTAL

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

Interventions

rtPA lock therapy DRUG

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.

Also known as: rtPA

rtPA lock therapy Recipients

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• subjects with short bowel syndrome
• requirement for central venous access device (CVAD) for long-term TPN administration
• age \>/= 6 months to \< 16 years
• ability to initiate rtPA during hospitalization for newly inserted CVAD
• ability to be enrolled within 48 hours of CVAD placement.

You may not qualify if:

• platelet count \<50,000
• active bleeding
• age =/\> 16 years at time of consent.

Sponsors & Collaborators

• Lynn Malec: lead
• University of Pittsburgh: collaborator

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lynn Malec
• Organization: BloodCenter of Wisconsin, Medical College of Wisconsin

lynn.malec@bcw.edu

414-257-2424

Study Officials

• Lynn Malec, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine and Pediatrics

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: February 4, 2015
• Study Start: February 1, 2015
• Primary Completion: September 3, 2016
• Study Completion: September 3, 2016
• Last Updated: February 6, 2018
• Results First Posted: February 6, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)