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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05209841
Other study ID # CSAPG-18
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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