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NCT Number: NCT01131754

Heparin 100U/L for Prevention of PVC Complications

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.

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Key information

Conditions

Peripheral Venous Catheter Complications Bites and Stings Blood Coagulation Disorders Cardiovascular Diseases Chemically-Induced Disorders Ecchymosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Occlusion Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Phlebitis Poisoning Signs and Symptoms Skin Manifestations Vascular Diseases Vasculitis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medicina 3 - IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

heparin 100U/L flushes

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 27, 2010
Registry last updated
Jun 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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