Heparinization vs Salinization of the Peripheral Venous Catheter

Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05209841

Collaborator

(none)

3,450

Enrollment

Location

Arms

4.5

Anticipated Duration (Months)

772.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Catheter Complications	Drug: Low dose heparin Drug: Normal saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 16, 2022

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Jul 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Catheter sealing with low dose heparin Catheters will be sealed with 3mL of Fibrillin Ⓡ (heparin 20UI/mL)	Drug: Low dose heparin Catheters will be sealed with 3 mL of Fibrillin Ⓡ (heparin 20UI/mL)
Active Comparator: Catheter sealing with normal saline Catheters will be sealed with 3mL of 0.9% sodium chloride	Drug: Normal saline Catheters will be sealed with 3mL of 0.9% sodium chloride

Arm

Intervention/Treatment

Experimental: Catheter sealing with low dose heparin

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

Drug: Low dose heparin

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

Active Comparator: Catheter sealing with normal saline

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

Drug: Normal saline

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

Outcome Measures

Primary Outcome Measures

Percentage of obstructed catheters [From date of randomization through the date of hospital discharge, an average of 10 days.]
percentage of obstructed catheters

Secondary Outcome Measures

Number of catheter-associated phlebitis [From date of randomization through the date of hospital discharge, an average of 10 days.]
Number of catheter-associated phlebitis
Number of catheter-associated bacterihemia episodes [From date of randomization through the date of hospital discharge, an average of 10 days.]
Number of catheter-associated bacterihemia episodes
Number of catheter loss due to extravasation [From date of randomization through the date of hospital discharge, an average of 10 days.]
Number of catheter loss due to extravasation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Residència Sant Camil	Sant Pere De Ribes	Barcelona	Spain	08810

Sponsors and Collaborators

Consorci Sanitari de l'Alt Penedès i Garraf

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Consorci Sanitari de l'Alt Penedès i Garraf

ClinicalTrials.gov Identifier:

NCT05209841

Other Study ID Numbers:

CSAPG-18

First Posted:

Jan 27, 2022

Last Update Posted:

Mar 10, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heparin

Study Results

No Results Posted as of Mar 10, 2022