Recombinant tissue plasminogen activator (alteplase) for restoration of flow in occluded central venous access devices: a double-blind placebo-controlled trial--the Cardiovascular Thrombolytic to Open Occluded Lines (COOL) efficacy trial
| Autor: | Patricia A. Hill, Donald J. Ponec, David Irwin, Edward R. McCluskey, William D. Haire, Xin Li |
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| Rok vydání: | 2001 |
| Předmět: |
Male
medicine.medical_specialty Catheterization Central Venous medicine.medical_treatment Placebo-controlled study Placebo law.invention Placebos Catheters Indwelling Randomized controlled trial Double-Blind Method Fibrinolytic Agents law Multicenter trial medicine Humans Radiology Nuclear Medicine and imaging Thrombus Urokinase business.industry Thrombosis Thrombolysis Middle Aged medicine.disease Surgery Catheter Treatment Outcome Anesthesia Tissue Plasminogen Activator Equipment Failure Female Cardiology and Cardiovascular Medicine business medicine.drug |
| Zdroj: | Journal of vascular and interventional radiology : JVIR. 12(8) |
| ISSN: | 1051-0443 |
| Popis: | Central venous access devices (CVADs) are a mainstay of current medical therapy but often become occluded by thrombus. Tissue plasminogen activator (alteplase), at a dose of 2 mg per 2 mL, has been shown to be effective in restoring flow to catheters proven by radiographic contrast injection to be occluded by thrombus. The purpose of this double-blind placebo-controlled multicenter trial was to determine the efficacy of alteplase in occluded catheters without earlier contrast injections or radiographic examinations.Patients were eligible for inclusion if blood could not be withdrawn from their catheter after a period of normal function of at least 48 hours. Single or multiple catheters, peripherally inserted central catheters, catheters with valves, and implanted ports were eligible; catheters used for hemodialysis were not included. Patients were randomly assigned to one of two groups. In one group, patients received a first dose of 2 mg alteplase followed, if needed, by a second dose of 2 mg alteplase and a third dose of placebo. The other group received placebo first followed by one 2-mg dose of alteplase and then a second, if needed. Each dose was allowed to dwell for 2 hours and ability to withdraw blood from the catheter was reassessed. The endpoint was restoration of the ability to withdraw and infuse through the catheter. One hundred forty-nine patients were randomized: 74 received placebo first, 75 received alteplase first.After the first 2-hour treatment, function was restored to 74% in the alteplase arm and 17% in the placebo arm (P.0001 compared to placebo). After one or two treatments, function was restored in 90% of patients. There were no serious study-drug-related adverse events, no intracranial hemorrhage, no major hemorrhage, and no embolic events.Infusion of alteplase appeared to be safe and effective in restoring flow to occluded catheters without need for pretreatment radiographic evaluation. |
| Databáze: | OpenAIRE |
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