Heparin Versus Normal Saline in Peripherally Inserted Central Catheter Lines

NCT05029596 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: STU-2018-0340
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The study team will be performing a study comparing the use of Heparin Flushes vs. Normal Saline Flushes in making sure central lines stay open. The participants will be placed in a group to receive the University of Texas Southwestern Medical Center (UTSW) Standard of Care (control group) for maintaining central lines, or a group to receive Normal Saline Flushes only (experimental group) to keep their central line open. The participants electronic medical record will be reviewed by study team members for the inclusion/exclusion criteria, the participants central line will be assessed by an 11 Blue BMT nurse every 12 hours, and they may be asked questions regarding their medical history during their stay on 11 Blue BMT. If a participant is discharged or transferred off of the 11 Blue BMT unit, they will no longer be included in the study and their central line maintenance will return to the UTSW Standard of Care. Participants in this study may be at risk for central line occlusion (a blood clot) which could require intervention to regain the free flow of fluids and use of the central line. The study team predicts there will be no increase in the rate of line occlusion when using Normal Saline Flushes only to maintain the free flow of fluids through participants central line. The study team also hopes the results of this study will help to improve patient outcomes by decreasing risk of infection, heparin associated complications, and costs.

Conditions

Cancer

Keywords

Peripherally Inserted Central Lines; Heparin Flush

Outcome Measures

Primary Outcomes (1)

• Patency

  To determine whether or not flushing central lines with normal saline only will maintain free flow through these central lines.

  Up to Day 7 of enrollment

Secondary Outcomes (1)

• Infection Rate

  From Day 1 and up to Day 7 of enrollment

Study Arms (2)

Heparin Group

ACTIVE COMPARATOR

Participants will receive the UTSW standard of of care for PICC line maintenance. All lumens of PICC line will be flushed w/ Heparin Flush every 8 hours. PICC line will be flushed with 10cc Normal Saline followed by 3cc Heparin Flush after administration of medication, blood products, or blood draws.

Drug: Heparin Group

Normal Saline Group

EXPERIMENTAL

Participants will receive only Normal Saline for PICC line maintenance. All lumens of PICC line will be flushed every 24 hours with 10cc Normal Saline. PICC line will be flushed with 10cc Normal Saline after administration of medication, blood products, or blood draws.

Drug: Normal Saline Group

Interventions

Normal Saline Group DRUG

A 10cc NS flush will be administered intravenously through the peripherally inserted central line catheter after administration of medication, blood products, and blood draws. In addition the peripherally inserted central line catheter will be flushed intravenously with 10cc Normal Saline every 24 hours.

Also known as: NS Flush, Normal Saline Flush, 0.9% Normal Saline Flush

Normal Saline Group

Heparin Group DRUG

All lumens of PICC line will be flushed w/ Heparin Flush every 8 hours. PICC line will be flushed with 10cc Normal Saline followed by 3cc Heparin Flush after administration of medication, blood products, or blood draws.

Also known as: Heparin Flush

Heparin Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Oncology patients
• Admitted to 11Blue Bone Marrow Transplant Unit at Clements University Hospital University of Texas Southwestern Medical Center
• Ages 18-80 years
• Pre-existing or newly placed PICC line
• PICC line with good blood return (defined as: "brisk blood return of 3cc")
• Flushes without difficulty

You may not qualify if:

• Patient less than 18 years of age or greater than 80 years of age
• Refused or unable to give consent to the study
• Patient admitted to the 11Blue BMT unit with any line other than a PICC line, or multiple lines
• Patient admitted to 11Blue BMT for active transplant
• Patient with a coagulopathy diagnosis
• Patient on therapeutic dose of anticoagulants for documented Deep Vein Thrombosis or Pulmonary Embolism
• Patient on inpatient hospice/comfort care
• Patient transferred off 11B BMT unit onto another floor

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Clements University Hospital

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Meredith C Allen, BSN

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Teresa Phan

  University of Texas Southwestern Medical Center

  STUDY CHAIR

• Linda Denke

  University of Texas Southwestern Medical Center

  STUDY DIRECTOR

• Kavitha Nair

  University of Texas Southwestern Medical Center

  STUDY CHAIR

• Miriam Gonzales

  University of Texas Southwestern Medical Center

  STUDY CHAIR

• Ramona Warkola

  University of Texas Southwestern Medical Center

  STUDY CHAIR

• Jancy Wilson

  University of Texas Southwestern Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 31, 2021
• Study Start: February 12, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)