The safety and efficacy of aeromedical central venous access

2005 ◽  
Vol 24 (5) ◽  
pp. 212-213
Author(s):  
D. Davis ◽  
P. Ramanujam ◽  
C. Buono
Keyword(s):  
Central Venous Access ◽  
Venous Access ◽  
Central Venous ◽  
Safety And Efficacy

Safety and Efficacy of Alfimeprase for Restoring Function in Occluded Central Venous Catheters: Interim Results of a Phase 2, Multicenter, Randomized, Double-Blind Study (NuCath).

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1768-1768 ◽  
Author(s):  
Steven R. Deitcher ◽  
Stephan Moll ◽  
Howard D. Homesley ◽  
Luigi Bertoli ◽  
Peter Kenyon ◽  
...  
Keyword(s):  
Patency Rate ◽  
Central Venous Access ◽  
Study Drug ◽  
Venous Access ◽  
Double Blind Study ◽  
Phase 2 ◽  
Central Venous ◽  
Bleeding Events ◽  
Double Blind ◽  
Safety And Efficacy

Abstract Alfimeprase, a recombinantly produced 22.6 kilodalton metalloproteinase, is a genetically modified variant of fibrolase. Alfimeprase, like fibrolase, proteolytically cleaves both the alpha and beta chains of fibrin(ogen) independent of plasminogen activation to plasmin and directly dissolves thrombi. Readily abundant alpha-2 macroglobulin acts as an endogenous circulating alfimeprase inactivator, forming a covalent, irreversible bond with alfimeprase which results in an inactive complex. Based on the direct thrombolytic effect of alfimeprase, rapid activity was hypothesized. We performed a Phase 2, randomized, double-blind, controlled, dose-ranging study to compare the safety and efficacy of one or two instillations of three intraluminal doses of alfimeprase (0.3 mg; 1.0 mg; and 3.0 mg) and Cathflo® Activase® (Genentech) 2.0 mg in reestablishing patency to occluded central venous access devices (CVADs). This report describes an interim analysis of 48 patients with CVAD withdrawal occlusion who were enrolled and randomized to treatment. Catheter patency was assessed at 5, 15, 30, and 120 minutes after each dose of study drug. Adverse events including bleeding events were assessed for a 30-day period after exposure to study drug. Cumulative patency rates are shown in the table. All study arms had similar patency rates at 120 minutes after the first dose. The alfimeprase 3.0 mg dose produced the highest patency rate at 120 minutes after the second dose. All three alfimeprase doses were more effective than Cathflo® Activase® during the first 30 minutes of treatment. The alfimeprase 1.0 mg and 3.0 mg doses resulted in ≥ 50% patency restoration rates at 15 minutes compared to 0% for Cathflo® Activase®. No intracranial hemorrhage, major hemorrhagic, or embolic events were reported in any treated patients at 5 days. Efficacy and safety results of this study support further evaluation of alfimeprase doses ranging from 1.0 mg to 3.0 mg for treatment of occluded CVADs. Cumulative Patency Rate (%) Alfimeprase 0.3 Alfimeprase 1 Alfimeprase 3 Cathflo Activase N=13 N=14 N=9 N=12 D=dose; min=minutes after dose Baseline 0 0 0 0 D 1; 5 min 15 14 44 0 D 1; 15 min 15 50 57 0 D 1; 30 min 30 50 57 25 D 1; 120 min 46 50 57 50 D 2; 5 min 46 50 57 58 D 2; 15 min 46 50 57 67 D 2; 30 min 46 50 57 67 D 2; 120 min 46 50 78 67

Safe and Cost Effective Use of Alteplase for the Clearance of Occluded Central Venous Access Devices

2002 ◽  
Vol 20 (7) ◽  
pp. 1918-1922 ◽  
Author(s):  
J. P. Timoney ◽  
M. G. Malkin ◽  
D. M. Leone ◽  
J. S. Groeger ◽  
M. L. Heaney ◽  
...  
Keyword(s):  
Thrombolytic Agent ◽  
Central Venous Access ◽  
Cost Effective ◽  
Venous Access ◽  
Central Venous ◽  
Safety And Efficacy ◽  
Reasonable Alternative ◽  
Effective Use ◽  
Assessment Initiative ◽  
Venous Access Devices

PURPOSE: To determine whether cryopreserved solutions of the thrombolytic agent alteplase could be used as a safe, effective, and economically reasonable alternative to urokinase in patients presenting with occluded central venous access devices (CVADs). MATERIALS AND METHODS: Alteplase has been reported as an efficacious alternative to urokinase for treatment of occluded CVADs. However, the practicality of using alteplase as the thrombolytic of choice for this indication remained conjectural. To make this approach economically feasible, alteplase was diluted to 1 mg/mL and 2.5-mL aliquots were stored at −20°C until use. A need to confirm that the cryopreserving and thawing of the reconstituted solution did not compromise the safety and efficacy reported from prior trials was recognized. A quality assessment initiative was undertaken to concurrently monitor the safety and efficacy of this approach. Patients presenting with occluded CVADs received a sufficient volume of the thawed alteplase solution to fill the occluded catheter(s). Data, including efficacy, adverse reactions, dwell time, and catheter type, were collected over a 5-month period. RESULTS: One hundred twenty-one patients accounting for 168 attempted clearances were assessable for safety and efficacy. One hundred thirty-six (81%) of the 168 catheter clearance attempts resulted in successful catheter clearance (95% confidence interval, 74% to 86%). No adverse events were reported. CONCLUSION: Cryopreserved 1-mg/mL aliquots of alteplase are safe and effective in the clearance of occluded CVADs when stored at −20°C for 30 days. The ability to cryopreserve alteplase aliquots makes it an economically reasonable alternative to urokinase in the setting of 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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