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Completed

NCT Number: NCT05029596

Heparin Versus Normal Saline in Peripherally Inserted Central Catheter Lines

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Clements University Hospital

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: NS Flush, Normal Saline Flush, 0.9% Normal Saline Flush

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.

Other names: Heparin Flush

Primary outcomes

  1. Patency

    Time frame: Up to Day 7 of enrollment

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

Secondary outcomes

  1. Infection Rate

    Time frame: From Day 1 and up to Day 7 of enrollment

    To determine whether or not removing Heparin Flushes from PICC line maintenance decreases the risk for central line associated infections

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Comparative Effectiveness of Heparin Versus Normal Saline in Maintaining Patency of Peripherally Inserted Central Catheter Lines in Oncology Inpatients

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2021
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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