Heparin 100U/L for Prevention of PVC Complications

This study has been completed.
Sponsor:
Information provided by:
IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT01131754
First received: May 26, 2010
Last updated: June 13, 2010
Last verified: February 2007
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Hematologic Diseases
Hemorrhage
Pathologic Processes
Peripheral Vascular Diseases
Signs and Symptoms
Skin Manifestations
Vascular Diseases
Vasculitis
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014