A Phase 3 interventional study of heparin 100U/L flushes in Peripheral Venous Catheter Complications, Occlusion and Phlebitis, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-06-15.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Phase 3, Interventional, and Prevention
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.
45 studies on the registry are indexed under Phlebitis; 9 are open to participants now.
This study's enrollment of 214 is above the median of 134 across 38 interventional studies indexed under Phlebitis.
Browse Phlebitis studies →Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 257 studies on the registry; 114 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
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.
Ecchymosis
Ecchymosis is defined as a purple discoloration of the skin around the catheter insertion site larger than 1 cm.
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.
The record gives a start of Jun 2007, a primary completion of Aug 2009 and a completion of Sep 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.
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