Heparinization vs Salinization of the Peripheral Venous Catheter

Heparinization vs Salinization of the Peripheral Venous Catheter: a Randomized Clinical Trial

Randomized, double-blind clinical trial to compare the efficacy of catheter sealing with saline, compared to low-dose heparin. 3,450 patients hospitalized at the Hospital Residencia Sant Camil, in Catalonia (Spain), will be randomized to each branch of study. The primary outcome will be the percentage of catheters removed due to obstruction in each branch of study. As secondary outcomes, the number of catheter-associated phlebitis, catheter-associated bacetrihemia, extravasation, and catheter loss will be measured. For the primary outcome, a superiority analysis will be carried out in terms of the percentage of obstructed catheters in each branch of the study.

Study Overview

• Status: Recruiting
• Conditions: Catheter Complications
• Intervention / Treatment: Drug: Low dose heparin; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Estimated): 3450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esther Moreno Rubio; Phone Number: 47158 938960025; Email: emoreno@csapg.cat
• Study Contact Backup: Name: Noemí Casaponsa; Phone Number: 43917 +34 938960025; Email: recerca@csapg.cat

Study Locations

• Spain
  • Barcelona
    • Sant Pere De Ribes, Barcelona, Spain, 08810
      • Recruiting
      • Hospital Residència Sant Camil
      • Contact: Noemí Casaponsa; Phone Number: 43917 +34 938960025; Email: recerca@csapg.cat
      • Contact: Esther Moreno Rubio; Phone Number: +34 938960025; Email: emoreno@csapg.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients older than 18 yo, admitted to the Hospital Residencia Sant Camil
• Patients with at least one peripheral venous line for discontinuous treatment, which has not been channeled in a medical emergency situation.
• Written informed consent

Exclusion Criteria:

• Allergy to heparin
• Patients treated with unfractionated sodium heparin.
• Patients in dialysis
• Patients with a venous catheter indicated for diagnosis tests.
• Patients with a venous catheter indicated for blood transfusion
• Severe heparin-induced thrombocytopenia in recent months
• Active uncontrollable bleeding during admission
• Brain aneurysm or dissecting aorta, except in association with corrective surgery.
• Confirmed / suspected cerebrovascular hemorrhage
• Severe uncontrolled hypertension
• Severe alterations in platelet coagulation <30,000, TP> 1.7 APTT ratio> 1.7 ratio.
• Patient included in another clinical trial with drugs or procedures that may affect the patency of venous catheters.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Catheter sealing with low dose heparin; Catheters will be sealed with 3mL of Fibrillin Ⓡ (heparin 20UI/mL)	Drug: Low dose heparin; Catheters will be sealed with 3 mL of Fibrillin Ⓡ (heparin 20UI/mL)
Active Comparator: Catheter sealing with normal saline; Catheters will be sealed with 3mL of 0.9% sodium chloride	Drug: Normal saline; Catheters will be sealed with 3mL of 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of obstructed catheters	percentage of obstructed catheters	From date of randomization through the date of hospital discharge, an average of 10 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of catheter-associated phlebitis	Number of catheter-associated phlebitis	From date of randomization through the date of hospital discharge, an average of 10 days.
Number of catheter-associated bacterihemia episodes	Number of catheter-associated bacterihemia episodes	From date of randomization through the date of hospital discharge, an average of 10 days.
Number of catheter loss due to extravasation	Number of catheter loss due to extravasation	From date of randomization through the date of hospital discharge, an average of 10 days.

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
• Investigators: Principal Investigator: Esther Moreno Rubio, CSAPG

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Catheterization, Peripheral; Catheter Obstruction
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: CSAPG-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
• IPD Sharing Time Frame: After publication of main results of the study
• IPD Sharing Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

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