Heparin 100U/L for Prevention of PVC Complications

NCT01131754 | Completed Phase 3

• 2 other identifiers: EPA 20072007-001347-21
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Venous Catheter Complications; Occlusion; Phlebitis; Ecchymosis

Keywords

Peripheral venous catheter complications; PVC occlusion; PVC phlebitis

Outcome Measures

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 (2)

• Ecchymosis

• Heparin induced thrombocytopenia

Study Arms (2)

Heparin sol 100U/L

EXPERIMENTAL

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

saline

ACTIVE COMPARATOR

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

Interventions

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.

Heparin sol 100U/L; saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• requiring i.v. therapy for an expected duration longer than five days
• admitted to the 3rd medical ward of IRCCS Policlinico San Matteo

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Medicina 3 - IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Bites and Stings; Phlebitis; Ecchymosis

Interventions

Heparin

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 27, 2010
• Study Start: June 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 15, 2010

Record last verified: 2007-02

Locations

IT (1)