Clinical trial NCT05029596: Heparin Versus Normal Saline in Peripherally Inserted Central Catheter Lines
Official title: Comparative Effectiveness of Heparin Versus Normal Saline in Maintaining Patency of Peripherally Inserted Central Catheter Lines in Oncology Inpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cancer
Keywords: Peripherally Inserted Central Lines
Heparin Flush
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Patency
timeFrame: Up to Day 7 of enrollment
Secondary outcomes:
measure: Infection Rate
timeFrame: From Day 1 and up to Day 7 of enrollment
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Clements University Hospital
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Meredith C Allen, BSN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center
name: Teresa Phan
role: STUDY_CHAIR
affiliation: University of Texas Southwestern Medical Center
name: Linda Denke
role: STUDY_DIRECTOR
affiliation: University of Texas Southwestern Medical Center
name: Kavitha Nair
role: STUDY_CHAIR
affiliation: University of Texas Southwestern Medical Center
name: Miriam Gonzales
role: STUDY_CHAIR
affiliation: University of Texas Southwestern Medical Center
name: Ramona Warkola
role: STUDY_CHAIR
affiliation: University of Texas Southwestern Medical Center
name: Jancy Wilson
role: STUDY_CHAIR
References: