scholarly journals Central venous access related adverse events after trabectedin infusions in soft tissue sarcoma patients; experience and management in a nationwide multi-center study

2017 ◽  
Vol 7 (1) ◽  
Author(s):  
Michiel C. Verboom ◽  
Jan Ouwerkerk ◽  
Neeltje Steeghs ◽  
Jacob Lutjeboer ◽  
J. Martijn Kerst ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Adverse Events ◽  
Central Venous Access ◽  
Venous Access ◽  
Central Venous ◽  
Multi Center Study ◽  
Patients Experience ◽  
Center Study

scholarly journals Skin Complications Associated With Pediatric Central Venous Access Devices: Prevalence, Incidence, and Risk

2019 ◽  
Vol 36 (5) ◽  
pp. 343-351
Author(s):  
Amanda J. Ullman ◽  
Tricia M. Kleidon ◽  
Karen Turner ◽  
Victoria Gibson ◽  
Anna Dean ◽  
...  
Keyword(s):  
Contact Dermatitis ◽  
Central Venous Access ◽  
Signs And Symptoms ◽  
Venous Access ◽  
Primary Diagnosis ◽  
Central Venous ◽  
Hazard Ratios ◽  
Multivariable Regression ◽  
Patients Experience ◽  
Venous Access Devices

Central venous access devices (CVADs) are vital to enable treatment for children with cancer and other complex health conditions. However, complications effecting the CVAD wound are commonly reported. This study aimed to identify the incidence and prevalence of CVAD-associated skin complications current management, and characteristics associated with complication development, in pediatrics. A prospective observational study performed across medical, oncology, and hematology departments at a tertiary pediatric hospital in Australia, between April and July 2017. Children admitted with CVADs were assessed twice weekly for CVAD-associated skin complications and associated signs and symptoms. The data were analyzed using descriptive statistics (i.e., proportions, frequency) and time-to-event multivariable regression (i.e., hazard ratios [HRs]). Two hundred and seventy-one CVADs were reviewed over 43,787 catheter days, with over one eighth of participants (14%; n = 37) having a CVAD-associated skin complication during their admission (0.95 per 1,000 catheter days, 95% confidence interval [CI; 0.61, 1.17]), most commonly contact dermatitis (11%; n = 29; 0.72 per 1,000 catheter days 95% CI [0.50, 1.04]). Within biweekly checks the median point prevalence of complications varied between 0.4% and 11% and clinical management was wide-ranging. A primary diagnosis of oncology (HR 2.89, 95% CI [1.10, 7.62]) or medical/surgical (HR 2.55, 95% CI [1.04, 6.22]) conditions; plain, nonbordered polyurethane dressings (HR 4.92, 95% CI [2.00, 12.13]); and poor dressing integrity (HR 2.64, 95% CI [1.18, 5.92]) were significantly associated with contact dermatitis. In conclusion, substantial numbers of pediatric patients experience CVAD-associated skin complications, and innovations are necessary to identify, prevent, and treat these health care–associated injuries.

scholarly journals Efficacy and safety associated with the use of the Surfacer® Inside-Out® Access Catheter System: Results from a prospective, multicenter Food and Drug Administration–approved Investigational Device Exemption study

2020 ◽  
pp. 112972982093712 ◽  
Author(s):  
Mahmood K Razavi ◽  
Eric K Peden ◽  
Ehab Sorial ◽  
John R Ross ◽  
John E Aruny ◽  
...  
Keyword(s):  
Adverse Events ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Central Venous Access ◽  
Venous Access ◽  
Venous Obstruction ◽  
Central Venous ◽  
Investigational Device Exemption ◽  
Inside Out ◽  
Central Venous Obstruction

Purpose: Thoracic central venous obstruction is commonly associated with the use of central venous catheters. The Surfacer System to Facilitate Access in Venous Occlusions Study was an Food and Drug Administration–approved US Investigational Device Exemption study designed to evaluate the performance and safety of the Surfacer System when used to facilitate central venous access in patients with thoracic central venous obstruction. Methods: Thirty patients were enrolled in this prospective, multicenter, single-arm study between December 2017 and May 2019. Device performance and adverse events were collected peri-procedurally and at discharge. Enrollment included 15 female and 15 male subjects with a mean age of 55.5 ± 12.9 (range: 30–79) years. Twenty-eight patients (93.3%) required central venous access for hemodialysis access. Locations of thoracic central venous obstruction were graded from 1 to 4 based on severity and extension of venous occlusions. Seven patients (23.3%) had type 1, 6 (20.0%) type 2, 16 (53.3%) type 3, and 1 (3.3%) type 4 obstruction. Results: Successful central venous catheter placement was achieved in 27 of 30 patients (90.0%). The procedure was discontinued in three (10.0%) due to tortuous anatomy discovered intraprocedurally. All 27 patients with successful CVC placement achieved adequate catheter patency and tip positioning with a mean overall procedural time and time to achieve central venous access with the Surfacer System being 44.1 ± 30.6 and 19.1 ± 25.1 min, respectively. There were no device-related adverse events or catheter malposition. Conclusion: The results of the SAVEUS Study confirm the safety and efficacy of the Surfacer System and the Inside-Out procedure when used for the placement of right-sided central venous access in patients with thoracic central venous obstruction.

Safety and Efficacy of Alfimeprase in Subjects with Occluded Central Venous Access Devices: The SONOMA-2 Study.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1866-1866
Author(s):  
Stephan Moll ◽  
Nashat Gabrail ◽  
Jim Buchanan ◽  
Mohammad Hirmand ◽  
Michael Levy ◽  
...  
Keyword(s):  
Adverse Events ◽  
Central Venous Access ◽  
Study Drug ◽  
Venous Access ◽  
Primary Efficacy ◽  
Primary Efficacy Endpoint ◽  
Central Venous ◽  
Treatment Groups ◽  
Venous Access Devices ◽  
Catheter Function

Abstract Introduction: The infusion of chemotherapy and blood products is facilitated by central venous access devices (CVAD), and the occurrence of thrombotic CVAD occlusion results in delays in these crucial therapies. Alfimeprase is a direct-acting thrombolytic agent with the potential to rapidly re-establish catheter function. Methods: SONOMA-2 was a multicenter, multinational, randomized, double blind, placebo-controlled phase 3 study evaluating the efficacy and safety of alfimeprase in subjects with occluded CVADs. Subjects were randomized in a 2:1 ratio to receive either intra-luminal alfimeprase (A) at a dose of 3.0 mg or placebo (P). Study drug was delivered in a total volume of 2 mL. If re-establishment of catheter function was not established within 30 minutes, a second dose of the same study drug was instilled and allowed to dwell for an additional 30 minutes. Re-establishment of catheter function was assessed by an attempt to withdraw 3 mL of blood and infuse 5 mL of saline. The primary efficacy endpoint was re-establishment of a functional CVAD at 15 minutes post first infusion. The primary efficacy analysis prespecified a significance level of ≤ 0.00125. Results: A total of 303 patients (201 (A), 102 (P)) were randomized into the study. Treatment groups were well balanced at baseline with respect to overall demographics, catheter insertion site, and median days since last failed infusion or blood draw. The primary efficacy endpoint, re-establishment of a functional CVAD at 15 minutes post first infusion, was achieved in 34.3% (A) versus 21.6% (P) of subjects (p = 0.022). The cumulative proportion of subjects with re-establishment of a functional CVAD at 30 minutes post first or second infusions was 52.7% (A) versus 30.4% (P) (p = 0.0002). Rates of adverse events (65.8% (A), 59.4% (P)), serious adverse events (15.5% (A), 16.8% (P)), and hemorrhagic adverse events (3.6% (A), 10.9% (P)) were comparable between treatment groups. No intracranial hemorrhages were observed. Conclusions: Alfimeprase restored CVAD function in a numerically greater fraction of subjects than did placebo; however, the study did not achieve statistical significance for the primary endpoint at the prespecified p-value of ≤ 0.00125 necessary for demonstrating efficacy with a single pivotal study. Alfimeprase was well tolerated. Further clinical studies are underway that evaluate a higher and more concentrated alfimeprase dose which preclinical studies predict will result in greater efficacy. Alfimeprase remains a promising potential candidate for use in patients with CVAD occlusion.

Successful Long-Term Central Venous Access

1998 ◽  
Vol 2 (1) ◽  
pp. 38-40
Author(s):  
Franco Tesio ◽  
Hamurabi De Baz ◽  
Giacomo Panarello
Keyword(s):  
Central Venous Access ◽  
Venous Access ◽  
Central Venous

Upper Extremity Deep Venous Thrombosis in Cancer Patients with Venous Access Devices - Prophylaxis with a Low Molecular Weight Heparin (Fragmin)

1996 ◽  
Vol 75 (02) ◽  
pp. 251-253 ◽  
Author(s):  
Manuel Monreal ◽  
Antoni Alastrue ◽  
Miquel Rull ◽  
Xavier Mira ◽  
Jordi Muxart ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Upper Extremity ◽  
Statistical Significance ◽  
Central Venous Access ◽  
Venous Access ◽  
Bleeding Complications ◽  
Fisher Exact Test ◽  
Central Venous ◽  
True Incidence ◽  
Venous Access Devices

SummaryCentral venous access devices are often essential for the administration of chemotherapy to patients with malignancy, but its use has been associated with a number of complications, mainly thrombosis. The true incidence of upper extremity deep vein thrombosis (DVT) in this setting is difficult to estimate since there are very few studies in which DVT diagnosis was based on objective tests, but its sequelae include septic thrombophlebitis, loss of central venous access and pulmonary embolism.We performed an open, prospective study in which all cancer patients who underwent placement of a long-term Port-a-Cath (Pharmacia Deltec Inc) subclavian venous catheter were randomized to receive or not 2500 IU sc of Fragmin once daily for 90 days. Venography was routinely performed 90 days after catheter insertion, or sooner if DVT symptoms had appeared. Our aims were: 1) to investigate the effectiveness of low doses of Fragmin in preventing catheter-related DVT; and 2) to try to confirm if patients with high platelet counts are at a higher risk to develop subclavian DVT, as previously suggested.On the recommendation of the Ethics Committee, patient recruitment was terminated earlier than planned: DVT developed in 1/16 patients (6%) taking Fragmin and 8/13 patients (62%) without prophylaxis (Relative Risk 6.75; 95% Cl: 1.05-43.58; p = 0.002, Fisher exact test). No bleeding complications had developed. As for prediction of DVT, there was a tendency towards a higher platelet count in those patients who subsequently developed DVT, but differences failed to reach any statistical significance (286 ±145 vs 207 ±81 X 109/1; p = 0.067). According to our experience, Fragmin at the dosage used proved to be both effective and safe in these patients.

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