Heparinization vs Salinization of the Peripheral Venous Catheter

Not Applicable

Recruiting

• Conditions: Catheter Complications
• Interventions: Drug: Low dose heparin; Drug: Normal saline

• Registration Number: NCT05209841
• Lead Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-27
• Study Start: 2022-04-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Primary Completion: 2025-07-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3450

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter sealing with low dose heparin	Low dose heparin	Catheters will be sealed with 3mL of Fibrillin Ⓡ (heparin 20UI/mL)
Catheter sealing with normal saline	Normal saline	Catheters will be sealed with 3mL of 0.9% sodium chloride

Primary Outcome Measures

Name	Time	Method
Percentage of obstructed catheters	From date of randomization through the date of hospital discharge, an average of 10 days.	percentage of obstructed catheters

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Residència Sant Camil; 🇪🇸 Sant Pere De Ribes, Barcelona, Spain