Heparin Versus Normal Saline in Peripherally Inserted Central Catheter Lines

NCT ID: NCT05029596

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-12
• Study Completion Date: 2023-03-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Heparin Group

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.

Group Type: ACTIVE_COMPARATOR

Heparin Group

Intervention Type: 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.

Normal Saline Group

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.

Group Type: EXPERIMENTAL

Normal Saline Group

Intervention Type: 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.

Interventions

Normal Saline Group

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.

Intervention Type: DRUG

Heparin Group

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.

Intervention Type: DRUG

Other Intervention Names

NS Flush, Normal Saline Flush, 0.9% Normal Saline Flush; Heparin Flush

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Meredith Allen

Registered Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meredith C Allen, BSN

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Teresa Phan

Role: STUDY_CHAIR

University of Texas Southwestern Medical Center

Linda Denke

Role: STUDY_DIRECTOR

University of Texas Southwestern Medical Center

Kavitha Nair

Role: STUDY_CHAIR

University of Texas Southwestern Medical Center

Miriam Gonzales

Role: STUDY_CHAIR

University of Texas Southwestern Medical Center

Ramona Warkola

Role: STUDY_CHAIR

University of Texas Southwestern Medical Center

Jancy Wilson

Role: STUDY_CHAIR

University of Texas Southwestern Medical Center

Locations

Clements University Hospital

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2018-0340

Identifier Type: -

Identifier Source: org_study_id