Back to resultsHeparin 100U/L for Prevention of PVC Complications
Primary Purpose
Peripheral Venous Catheter Complications, Occlusion, Phlebitis
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
heparin 100U/L flushes
Sponsored by
About this trial
This is an interventional prevention trial for Peripheral Venous Catheter Complications focused on measuring Peripheral venous catheter complications, PVC occlusion, PVC phlebitis
Eligibility 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
Sites / Locations
- Medicina 3 - IRCCS Policlinico San Matteo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Heparin sol 100U/L
saline
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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.
Full Information
NCT ID
NCT01131754
First Posted
May 26, 2010
Last Updated
June 13, 2010
Sponsor
IRCCS Policlinico S. Matteo
1. Study Identification
Unique Protocol Identification Number
NCT01131754
Brief Title
Heparin 100U/L for Prevention of PVC Complications
Official Title
STUDIO CLINICO RANDOMIZZATO SULL'UTILIZZO DI EPARINA PER LA PROFILASSI DELLA TROMBOFLEBITE DA CATETERE VENOSO PERIFERICO
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
IRCCS Policlinico S. Matteo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Venous Catheter Complications, Occlusion, Phlebitis, Ecchymosis
Keywords
Peripheral venous catheter complications, PVC occlusion, PVC phlebitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heparin sol 100U/L
Arm Type
Experimental
Arm Description
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.
Arm Title
saline
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
heparin 100U/L flushes
Intervention Description
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 Measure Information:
Title
Phlebitis or Occlusion
Description
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 Measure Information:
Title
Ecchymosis
Description
Ecchymosis is defined as a purple discoloration of the skin around the catheter insertion site larger than 1 cm.
Title
Heparin induced thrombocytopenia
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Medicina 3 - IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
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Heparin 100U/L for Prevention of PVC Complications
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