Heparinization vs Salinization of the Peripheral Venous Catheter
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low dose heparin, Normal saline.
- Who it may be relevant to
- Registry conditions: Catheter Complications. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Heparinization vs Salinization of the Peripheral Venous Catheter: a Randomized Clinical Trial
Overview
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.
Interventions
- Drug Low dose heparin
Catheters will be sealed with 3 mL of Fibrillin Ⓡ (heparin 20UI/mL) - Drug Normal saline
Catheters will be sealed with 3mL of 0.9% sodium chloride
Primary outcome measures
- Percentage of obstructed catheters [Time frame: From date of randomization through the date of hospital discharge, an average of 10 days.]
Secondary outcome measures (3)
- Number of catheter-associated phlebitis [Time frame: From date of randomization through the date of hospital discharge, an average of 10 days.]
- Number of catheter-associated bacterihemia episodes [Time frame: From date of randomization through the date of hospital discharge, an average of 10 days.]
- Number of catheter loss due to extravasation [Time frame: From date of randomization through the date of hospital discharge, an average of 10 days.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Spain · 1 center
- Hospital Residència Sant Camil — Sant Pere de Ribes
Identifiers
NCT: NCT05209841 · CSAPG-18