An observational study in Upper Extremity Deep Vein Thrombosis, sponsored by Azienda Ospedaliera S. Maria della Misericordia. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Azienda Ospedaliera S. Maria della Misericordia · Observational
Most important peripherally inserted central catheter (PICC) and Midline complications are thrombosis and catheter related blood stream infections. No large prospective observational study are present in literature about these topics. The aim of this multicenter prospective observational study is to analyze all the complications due to PICC and Midline insertion.
A PICC line is a Peripherally Inserted Central Catheter. It is long, small, flexible tube that is inserted into a peripheral vein, typically in the upper arm, and terminates in a large vein in the chest to obtain a central intravenous access. A Midline catheter is similar to a PICC, but it is shorter in length (about 25 cm) and is inserted into a large vein in the upper arm, terminating not beyond the axillary vein. Midline catheters offer a longer dwell time and better hemodilution than the short peripheral IV catheters.The use of PICC and Midline has been increasing in outpatient and inpatient settings. Factors driving this increased use include their ease of insertion due to the placement into a peripheral vein-a safer approach-with the benefit of a central tip location appropriate for any osmolarity and pH infusions, a low reported incidence of infection, a better patient comfort, a durable venous access, and an easier nursing management in outpatient setting. PICC placement under ultrasound guidance can be carried out with no iatrogenic, mechanical complications associated with central venous catheter insertion in the neck or chest (pneumothorax, hemothorax etc...). Despite their many advantages, recent data suggest that PICCs are associated with venous thromboembolism. The incidence of symptomatic thrombosis ranges from 1.9% to 8.4% and it increases to 75% considering also the asymptomatic one. The risk factors that predispose a patient to the development of a thrombotic complication are: the caliber of the device (≥5Fr), the position of the catheter tip, the insertion of the PICC in a paretic limb, a history of venous thrombosis, the residence time of the device and the presence of an oncological pathology. The second major complication due to the PICC insertion is the catheter related blood stream infection (CRBSI). The incidence of PICC-BSI in literature ranges from 2.0 per 1000 catheter days to 3.1 per 1000 catheter days. This disparity stems from the fact that there is no single definition of catheter infection. Multiple factors associated with patient and catheter care have been identified has having an increased risk of CRBSI and are amenable to preventive measures. Independent risk factors for PICC BSIs included congestive heart failure, intrabdominal perforation, Clostridium difficile infection, recent chemotherapy, presence of tracheostomy, and type of catheter (double or tri lumen). Limited data exists regard prospective observational study on deep vein thrombosis and CRBSI related to PICC and Midline insertion, including the different calibers of the device and the presence of single or multiple lumen.
The investigators designed a multicenter prospective observational study to determine the incidence of deep vein thrombosis, related/associated catheter blood stream infections and the incidence of all the minor complications due to PICC and Midline insertion.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 547 is above the median of 213 across 586 observational studies indexed under Thrombosis.
Browse Thrombosis studies →Azienda Ospedaliera S. Maria della Misericordia is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will be conducted in all the patients undergoing PICC or Midline catheter insertion which fall in the inclusion criteria
Exclusion Criteria:
Peripherally inserted central venous catheter
Prevalence of deep venous thrombosis (DVT) occurring after the PICC placement in all patients
Time frame: 2 years
Prevalence of infections related catheter
Time frame: 2 years
Prevalence of other complications such as phlebitis, occlusion, malposition
Time frame: 2 years
Reason of the catheter removal
Time frame: 2 years
Prevalence of the same complications Midline related
Time frame: 2 years
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera S. Maria della Misericordia