Clinical trial NCT05209841: Heparinization vs Salinization of the Peripheral Venous Catheter
Official title: Heparinization vs Salinization of the Peripheral Venous Catheter: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Catheter Complications
Keywords: Catheterization, Peripheral
Catheter Obstruction
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 3450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of obstructed catheters
timeFrame: From date of randomization through the date of hospital discharge, an average of 10 days.
Secondary outcomes:
measure: Number of catheter-associated phlebitis
timeFrame: From date of randomization through the date of hospital discharge, an average of 10 days.
measure: Number of catheter-associated bacterihemia episodes
timeFrame: From date of randomization through the date of hospital discharge, an average of 10 days.
measure: Number of catheter loss due to extravasation
timeFrame: From date of randomization through the date of hospital discharge, an average of 10 days.
Other outcomes:
Locations:
city: Sant Pere De Ribes
country: Spain
facility: Hospital Residència Sant Camil
state: Barcelona
Study officials:
affiliation: CSAPG
name: Esther Moreno Rubio
role: PRINCIPAL_INVESTIGATOR
References: