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NCT Number: NCT05209841

Heparinization vs Salinization of the Peripheral Venous Catheter

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.

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Key information

Conditions

Catheter Complications

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low dose heparin

Drug

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

normal saline

Drug

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

Primary outcomes

  1. Percentage of obstructed catheters

    Time frame: From date of randomization through the date of hospital discharge, an average of 10 days.

    percentage of obstructed catheters

Secondary outcomes

  1. 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 phlebitis

  2. 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-associated bacterihemia episodes

  3. Number of catheter loss due to extravasation

    Time frame: From date of randomization through the date of hospital discharge, an average of 10 days.

    Number of catheter loss due to extravasation

Study contacts

Contact information is provided by the study sponsor or research team.

Esther Moreno Rubio

CONTACT

[email protected]

938960025 ext. 47158

Noemí Casaponsa

CONTACT

[email protected]

+34 938960025 ext. 43917

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2022
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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