Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 69 of 1001 for:    Heparin sodium

Heparin 100U/L for Prevention of PVC Complications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01131754
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : June 15, 2010
Sponsor:
Information provided by:
IRCCS Policlinico S. Matteo

Brief Summary:
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 or disease Intervention/treatment Phase
Peripheral Venous Catheter Complications Occlusion Phlebitis Ecchymosis Other: heparin 100U/L flushes Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: STUDIO CLINICO RANDOMIZZATO SULL'UTILIZZO DI EPARINA PER LA PROFILASSI DELLA TROMBOFLEBITE DA CATETERE VENOSO PERIFERICO
Study Start Date : June 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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.




Primary Outcome Measures :
  1. 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 :
  1. Ecchymosis
    Ecchymosis is defined as a purple discoloration of the skin around the catheter insertion site larger than 1 cm.

  2. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131754


Locations
Layout table for location information
Italy
Medicina 3 - IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
IRCCS Policlinico S. Matteo

Layout table for additonal information
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 ( EudraCT Number )
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: June 15, 2010
Last Verified: February 2007

Keywords provided by IRCCS Policlinico S. Matteo:
Peripheral venous catheter complications
PVC occlusion
PVC phlebitis

Additional relevant MeSH terms:
Layout table for MeSH terms
Heparin
Calcium heparin
Phlebitis
Ecchymosis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action