Heparinization vs Salinization of the Peripheral Venous Catheter

Consorci Sanitari de l'Alt Penedès i Garraf

Status: Enrolling

Conditions: Catheter Complications

Treatments: Drug: Normal saline; Drug: Low dose heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT05209841

CSAPG-18

Details and patient eligibility

About

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.

Enrollment: 3,450 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3,450 participants in 2 patient groups

Catheter sealing with low dose heparin

Experimental group

Description:

Catheters will be sealed with 3mL of Fibrillin Ⓡ (heparin 20UI/mL)

Treatment:

Drug: Low dose heparin

Catheter sealing with normal saline

Active Comparator group

Description:

Catheters will be sealed with 3mL of 0.9% sodium chloride

Treatment:

Drug: Normal saline