NEWS HIGHLIGHTS RELATED TO CATHFLO ACTIVASE
Published Studies Related to Cathflo Activase (Alteplase)
Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. [2008.09.25]
BACKGROUND: Intravenous thrombolysis with alteplase [generic for Cathflo Activase] is the only approved treatment for acute ischemic stroke, but its efficacy and safety when administered more than 3 hours after the onset of symptoms have not been established. We tested the efficacy and safety of alteplase administered between 3 and 4.5 hours after the onset of a stroke... CONCLUSIONS: As compared with placebo, intravenous alteplase administered between 3 and 4.5 hours after the onset of symptoms significantly improved clinical outcomes in patients with acute ischemic stroke; alteplase was more frequently associated with symptomatic intracranial hemorrhage. (ClinicalTrials.gov number, NCT00153036.) 2008 Massachusetts Medical Society
Comparison of alteplase and heparin in maintaining the patency of paediatric central venous haemodialysis lines: a randomised controlled trial. [2007.06]
OBJECTIVES: To determine whether the tissue plasminogen activator, alteplase [generic for Cathflo Activase], is more effective than heparin in preventing blood clots developing in children's haemodialysis central lines between dialysis sessions... CONCLUSION: Alteplase is significantly more effective than heparin in preventing clot formation in central haemodialysis lines. This reduces morbidity and improves preservation of central venous access. It is more expensive, though relatively economic if packaged into syringes and stored frozen until needed, but reduces the costs of unblocking or replacing clotted lines.
Short and long alteplase dwells in dysfunctional hemodialysis catheters. [2005.04]
BACKGROUND: Hemodialysis catheter dysfunction (CD) is the inability to attain adequate blood pump speeds (BPS) and is attributed to thrombus or catheter malposition; alteplase [generic for Cathflo Activase] (TPA) is often given in a variety of dwell times to treat CD. The purpose of this study was to determine if TPA dwell time affects short- or long-term catheter patency rates... CONCLUSION: This study demonstrates that although patency for the next HD run can be achieved with either short or long TPA dwell, neither is reliable in terms of long-term patency. Strategies that employ TPA for CD are temporary and allow a 2-week window during which more definitive therapies for HD access should be sought.
Comparison of rapidity of coronary recanalization in men with tenecteplase versus alteplase in acute myocardial infarction. [2004.06.15]
To determine whether tenecteplase (TNK-t-PA), a bioengineered variant of tissue-type plasminogen activator (t-PA) designed to accelerate thrombolysis, exhibits favorable properties compared with those of alteplase [generic for Cathflo Activase], 266 men were studied </=6 hours after the onset of symptoms and signs of acute myocardial infarction... TNK-t-PA appears to induce recanalization more rapidly than alteplase, and thrombolysis initiated early after the onset of symptoms is associated with remarkably low mortality.
Effect of activated protein C on plasma plasminogen activator inhibitor activity in patients with acute myocardial infarction treated with alteplase: comparison with unfractionated heparin. [2003.10.15]
OBJECTIVES: We examined whether activated protein C (APC) is an effective conjunctive therapy to thrombolysis in patients with ST-segment-elevated acute myocardial infarction (AMl). BACKGROUND: Activated protein C possesses both systemic anticoagulant and anti-inflammatory properties. It has been also shown to enhance fibrinolysis by inhibiting plasminogen activator inhibitor (PAI) activity in vitro... CONCLUSIONS: Administration of APC suppressed increasing of plasma PAI activity observed after thrombolysis in patients with AMI. The effect of APC could be more eligible, compared with heparin, as a conjunctive regimen to thrombolysis in AMI patients.
Clinical Trials Related to Cathflo Activase (Alteplase)
Cathflo Activase Pediatric Study [Completed]
This was a Phase IV, open-label, single-arm, multicenter trial that was to be conducted at
~60 sites in the United States. Approximately 300 pediatric subjects with dysfunctional
CVADs (including catheters with valves, multiple lumens, umbilical catheters, and implanted
ports) were to be treated with up to two serially instilled doses of Cathflo Activase.
Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III [Not yet recruiting]
The overall objective of this Phase III clinical trial is to obtain information from a
population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of
current clinical practice and national demographics of ICH regarding the benefit (or lack
thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS).
This application requests funding for five years to initiate a Phase III randomized clinical
trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The
investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue
plasminogen activator (rt-PA, Cathflo® Activase® Genentech, Inc., San Francisco, CA) with
EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage
(ICH) and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of
the 3rd or 4th ventricles by intraventricular blood clot).
Safety and Efficacy of Tissue Plasminogen Activator (tPA) in Neonates and Infants [Recruiting]
Phase II Clinical Trial on Treatment of Intraventricular Hemorrhage [Recruiting]
The specific objective of this trial is to determine the lowest dose possible with the best
pharmacokinetic and safety profile and it's ability to remove a blood clot from the
ventricular system.
Alteplase for Blood Flow Restoration in Hemodialysis Catheters [Recruiting]
We are investigating a new way of administering alteplase to remove clots from hemodialysis
catheters. Currently, alteplase is left to dwell inside the catheter between dialysis
treatments to dissolve the clot and restore blood flow through the catheter. We have
developed a new way to administer alteplase by advancing it to the tip of the catheter at
regular 10 minute intervals. We hypothesize that our new "push" protocol will dissolve clots
in hemodialysis catheters better and faster than the current dwell method.
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