Heparin 100U/L for Prevention of PVC Complications

STUDIO CLINICO RANDOMIZZATO SULL'UTILIZZO DI EPARINA PER LA PROFILASSI DELLA TROMBOFLEBITE DA CATETERE VENOSO PERIFERICO

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.

Study Overview

• Status: Completed
• Conditions: Phlebitis; Occlusion; Ecchymosis; Peripheral Venous Catheter Complications
• Intervention / Treatment: Other: heparin 100U/L flushes

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Medicina 3 - IRCCS Policlinico San Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
Phlebitis or Occlusion	Phlebitis is defined as the presence of two or more symptoms/signs among pain, tenderness, warmth, erythema, swelling, or a palpable cord (score of ≥ 2 according to the Visual Infusion Phlebitis Score). Occlusion is defined as resistance to flushing as evidenced by the inability to administer 1 ml of flushing solution within 30 seconds.

Secondary Outcome Measures

Outcome Measure	Measure Description
Ecchymosis	Ecchymosis is defined as a purple discoloration of the skin around the catheter insertion site larger than 1 cm.
Heparin induced thrombocytopenia	Heparin induced thrombocytopenia is defined as a fall in platelet count > 50% of baseline value without any alternative explanation. To detect this phenomenon, platelet count is to be performed at baseline and, subsequently, every 5 days.

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: May 26, 2010
• First Posted (Estimate): May 27, 2010

Study Record Updates

• Last Update Posted (Estimate): June 15, 2010
• Last Update Submitted That Met QC Criteria: June 13, 2010
• Last Verified: February 1, 2007

More Information

Terms related to this study

• Keywords: Peripheral venous catheter complications; PVC occlusion; PVC phlebitis
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhage; Vasculitis; Blood Coagulation Disorders; Skin Manifestations; Peripheral Vascular Diseases; Ecchymosis; Phlebitis; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: EPA 2007; 2007-001347-21 (EudraCT Number)