Heparinization vs Salinization of the Peripheral Venous Catheter

Catheter Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05209841
• Other study ID #: CSAPG-18
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: July 30, 2025

Study information

• Verified date: March 2024
• Source: Consorci Sanitari de l'Alt Penedès i Garraf
• Contact: Esther Moreno Rubio
• Phone: 938960025
• Email: emoreno[@]csapg.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3450
• Est. completion date: July 30, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Catheter Complications

Intervention

Drug:
• Low dose heparin
Catheters will be sealed with 3 mL of Fibrillin ? (heparin 20UI/mL)
• Normal saline
Catheters will be sealed with 3mL of 0.9% sodium chloride

Locations

Country	Name	City	State
Spain	Hospital Residència Sant Camil	Sant Pere De Ribes	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of obstructed catheters	percentage of obstructed catheters	From date of randomization through the date of hospital discharge, an average of 10 days.
Secondary	Number of catheter-associated phlebitis	Number of catheter-associated phlebitis	From date of randomization through the date of hospital discharge, an average of 10 days.
Secondary	Number of catheter-associated bacterihemia episodes	Number of catheter-associated bacterihemia episodes	From date of randomization through the date of hospital discharge, an average of 10 days.
Secondary	Number of catheter loss due to extravasation	Number of catheter loss due to extravasation	From date of randomization through the date of hospital discharge, an average of 10 days.