Normal Saline Versus Heparin Intermittent Flushing for the Prevention of Occlusion in Port-a-Cath

Normal Saline Versus Heparin Intermittent Flushing for the Prevention of Occlusion in Port-a-Cath: Randomized Controlled Trial

Purpose:

An evidence implementation of a randomized controlled trial for whether there is the difference in intermittent flushing 0.9% normal saline and heparin? Design: a single-blind randomized controlled trial

Method:

This study is based on the 5A (Ask, Acquire, Appraise, Apply, Audit) of evidence health care step, and design randomized controlled trial for evidence implementation.

We will include inpatients over 20 years-old adults in New Taipei City TuCheng Hospital, Taiwan, who need administration medicine by port-a-catcher. The sample size is 192 according to G-power software. Random allocation software has using for block randomization, would assign to group A: flushing with 0.9% normal saline 10ml, group B: flushing with 0.9% normal saline 20ml, and group C: flushing with heparin 100 USP/ml. SPSS 20.0 software for statistical analysis, mean or standard deviation, one- way ANOVA would use.

Study Overview

• Status: Not yet recruiting
• Conditions: Port-a-cath Occlusion; Normal Saline; Heparin Lock
• Intervention / Treatment: Drug: Normal Saline Flush 20 ml; Drug: Normal Saline Flush 10 ml; Drug: Heparin Flush (1000 USP, 10ml)

• Study Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Non-pediatric inpatients over 20 years of age with PAC placed for any disease and who need medication during hospitalization.

Exclusion Criteria:

History of PAC obstruction, continuous high volume drip via PAC, taking anticoagulant or antiplatelet agents, abnormal blood coagulation, pregnancy or contraceptive use, specified flushing solution by case

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Normal saline 20 ml	Drug: Normal Saline Flush 20 ml; Normal Saline Flush 20 ml
EXPERIMENTAL: Normal saline 10 ml	Drug: Normal Saline Flush 10 ml; Normal Saline Flush 10 ml
ACTIVE_COMPARATOR: usual care (heparin)	Drug: Heparin Flush (1000 USP, 10ml); Heparin Flush (1000 USP, 10ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
port-a-cath occlusion	failure to infusion fluid	in hospitalized (during admission), up to 12 weeks
port-a-cath infection	blood culture from port-A show bacterial growth	in hospitalized (during admission), up to 12 weeks

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (ACTUAL): February 1, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Flushing; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: CMRPVVM0141

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No