Heparin 100U/L for Prevention of PVC Complications

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-09-30

Brief Summary

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Flushes with saline solution are used for maintaining patency of peripheral intermittent intravenous catheters in many institution based on the results of previous studies showing that 10 U heparin/mL is not better than saline in this respect. The latest meta-analysis investigated also safety and efficacy of heparin concentrations of 100 U/ml used as an intermittent flush, but no firm conclusion was reached because of limitations of the few available studies.

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Detailed Description

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Conditions

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Peripheral Venous Catheter Complications Occlusion Phlebitis Ecchymosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Heparin sol 100U/L

peripheral venous catheter flushing with 3 mL of a 100 U heparin/mL normal saline from mono-use vial (Epsodilave, Mayne Pharma, Naples, Italy) at the end of each drug infusion. Independently from the number of drug infusions, all patients will receive at least two catheter flushes every day.

Group Type EXPERIMENTAL

heparin 100U/L flushes

Intervention Type OTHER

peripheral venous catheter flushing with 3 mL of a 100 U heparin/mL normal saline from mono-use vial (Epsodilave, Mayne Pharma, Naples, Italy) at the end of each drug infusion. Independently from the number of drug infusions, all patients will receive at least two catheter flushes every day.

saline

peripheral venous catheter flushing with 3 mL of normal saline from mono-use vials (prepared by the hospital pharmacy) at the end of each drug infusion. Independently of the number of drug infusions, all patients will receive at least two catheter flushes every day.

Group Type ACTIVE_COMPARATOR

heparin 100U/L flushes

Intervention Type OTHER

peripheral venous catheter flushing with 3 mL of a 100 U heparin/mL normal saline from mono-use vial (Epsodilave, Mayne Pharma, Naples, Italy) at the end of each drug infusion. Independently from the number of drug infusions, all patients will receive at least two catheter flushes every day.

Interventions

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heparin 100U/L flushes

peripheral venous catheter flushing with 3 mL of a 100 U heparin/mL normal saline from mono-use vial (Epsodilave, Mayne Pharma, Naples, Italy) at the end of each drug infusion. Independently from the number of drug infusions, all patients will receive at least two catheter flushes every day.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* requiring i.v. therapy for an expected duration longer than five days
* admitted to the 3rd medical ward of IRCCS Policlinico San Matteo

Exclusion Criteria

* bleeding tendency
* platelet count less than 100 x 109/L
* coagulation defects
* previous adverse reaction to heparin
* programmed cytotoxic therapy
* inability to give an informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No