Heparin 100U/L for Prevention of PVC Complications - Full Text View

Purpose

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.

Condition	Intervention	Phase
Peripheral Venous Catheter Complications Occlusion Phlebitis Ecchymosis	Other: heparin 100U/L flushes	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	STUDIO CLINICO RANDOMIZZATO SULL'UTILIZZO DI EPARINA PER LA PROFILASSI DELLA TROMBOFLEBITE DA CATETERE VENOSO PERIFERICO

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Heparin

U.S. FDA Resources

Further study details as provided by IRCCS Policlinico S. Matteo:

Primary Outcome Measures:

Phlebitis or Occlusion [ Designated as safety issue: Yes ]
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:

Ecchymosis [ Designated as safety issue: Yes ]
Ecchymosis is defined as a purple discoloration of the skin around the catheter insertion site larger than 1 cm.
Heparin induced thrombocytopenia [ Designated as safety issue: Yes ]
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.

Enrollment:	214
Study Start Date:	June 2007
Study Completion Date:	September 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131754

Locations

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

Sponsors and Collaborators

IRCCS Policlinico S. Matteo

More Information

No publications provided

Responsible Party:	Carlo Balduini, Medicina 3 - Fondazione IRCCS Policlinico San Matteo
ClinicalTrials.gov Identifier:	NCT01131754 History of Changes
Other Study ID Numbers:	EPA 2007, 2007-001347-21
Study First Received:	May 26, 2010
Last Updated:	June 13, 2010
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by IRCCS Policlinico S. Matteo:

Peripheral venous catheter complications
PVC occlusion
PVC phlebitis

Additional relevant MeSH terms:

Ecchymosis
Phlebitis
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

Vasculitis
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013