NCT01405534 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Burns KE, McLaren A
Catheter-related right atrial thrombus and pulmonary embolism: a case report and systematic review of the literature. Can Respir J. 2009 Sep-Oct;16(5):163-5. Review.
Centers for Disease Control and Prevention (CDC)
Vital signs: central line-associated blood stream infections--United States, 2001, 2008, and 2009. MMWR Morb Mortal Wkly Rep. 2011 Mar 4;60(8):243-8.
Gambotti L, Pérol D, Frering B, Kaemmerlen P, Coronel B, Sebban H, Bulso V, Bachelot V, Chauvin F, Bachmann P
Safety of percutaneous internal jugular catheterization in cancer patients: prospective observational study. J Vasc Access. 2004 Oct-Dec;5(4):161-7.
Kim HJ, Yun J, Kim HJ, Kim KH, Kim SH, Lee SC, Bae SB, Kim CK, Lee NS, Lee KT, Park SK, Won JH, Park HS, Hong DS
Safety and effectiveness of central venous catheterization in patients with cancer: prospective observational study. J Korean Med Sci. 2010 Dec;25(12):1748-53. doi: 10.3346/jkms.2010.25.12.1748. Epub 2010 Nov 24.
Maki DG, Kluger DM, Crnich CJ
The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc. 2006 Sep;81(9):1159-71. Review.
Yacopetti N, Alexandrou E, Spencer TR, Frost SA, Davidson PM, O'Sullivan G, Hillman KM
Central venous catheter insertion by a clinical nurse consultant or anaesthetic medical staff: a single-centre observational study. Crit Care Resusc. 2010 Jun;12(2):90-5.

Evaluation of the Occurrence of Acute Complications Caused by a Central Venous Catheter Placement: Observational, Prospective, Monocentric Study

Clinical trial NCT01405534 - References