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

May 26, 2010
June 13, 2010
June 2007
August 2009   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01131754 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Peripheral Venous Catheter Complications
  • Occlusion
  • Phlebitis
  • Ecchymosis
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.
  • 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.
    Intervention: Other: heparin 100U/L flushes
  • 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.
    Intervention: Other: heparin 100U/L flushes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
214
September 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01131754
EPA 2007, 2007-001347-21
No
Carlo Balduini, Medicina 3 - Fondazione IRCCS Policlinico San Matteo
IRCCS Policlinico S. Matteo
Not Provided
Not Provided
IRCCS Policlinico S. Matteo
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP