Clinical Trial Results

Cathflo® Activase® (alteplase) is integral to evidence-based practices for treating thrombotically occluded catheters

Cathflo efficacy and safety were demonstrated in adult and pediatric patients with improperly functioning central venous access devices (CVADs)2,8,10

The Cathflo clinical trials were large trials with prespecified endpoints in children and adults. In the pivotal trials COOL-1 and COOL-2, the efficacy and safety of Cathflo were evaluated in 1122 primarily adult patients, while CAPS evaluated 310 pediatric patients ages ranging from 2 weeks to 17 years.2,8,10

Trial Design
 Efficacy Safety
  Primarily Adult Patients Pediatric Patients
Trial COOL-1
Double‑blind, randomized, placebo‑controlled study		 COOL-2
Phase III, single‑arm, open‑label, multicenter study		 CAPS
Open‑label, single‑arm trial
Patient enrollment (n) 150 995 310
Mean age (years) 50.1 50.7 7.2
Primary objective Evaluate the efficacy of Cathflo 2 mg/2 mL, in up to 2 doses, with function assessed at 120 min8 Evaluate the safety of serial administration of up to 2 doses of Cathflo Evaluate the safety of Cathflo, as measured by the incidence of intracranial hemorrhage (ICH) in a maximum of 2 doses at ≤2 mg per dose
Secondary objective Determine the rate of catheter function restoration after 1 or 2 Cathflo treatments22 Included assessing success rates at 30 minutes and 120 minutes10 Included assessing restoration rates at 30 minutes and 120 minutes, and serious adverse eventes within 48 hours2,8
Primarily Adult Patients Pediatric Patients
Cumulative efficacy

88%
COOL-1: Cathflo restored function to 88% (112/127) of central lines after up to 2 doses using a 120-minute dwell time for each in catheters with occlusions present for up to 24 hours.8

COOL-1 AND COOL-2: Cathflo restored function to 68% (796/1043) of central lines after 1 dose and 88% (902/1043) of central lines after 2 doses in catheters with occlusions present for less than 14 days.8

 83%
CAPS: Cathflo restored function in 83% (257/310) of central lines after up to 2 doses using a 120-minutes dwell time for each.8
First dose efficacy
75%
COOL-2: Cathflo restored function after 1 dose in 75% (747/995) of central lines after up to 120 minutes of dwell time in catheters with occlusions present for any duration.8		 75%
CAPS: Cathflo restored function after 1 dose in 75% (233/310) of central lines after up to 120 minutes of dwell time.2
Occlusions > 14 days efficacy Rapid restoration
72%
COOL-2: Cathflo restored function to 57% (30/53) of central lines after 1 dose and 72% (38/53) of central lines after up 2 doses in catheters with occlusions present for longer than 14 days.8		 54%
CAPS: Cathflo restored function within 30 minutes in 54% (166/310) of central lines.2
Maintained patency
74%
In a subset of patients (n=346) who had a successful treatment outcome, 74% (256/346) of central lines maintained patency up to 30 days after treatment with Cathflo.10
Serious Adverse
Events %		 Adult
COOL-1 and COOL-2
(n=122)		 Pediatric
CAPS
(n=310)
Catheter-related complication - 1.3%*
Sepsis 0.4% 1.0%
Fever - <1.0%
Major hemorrhage 0.4% 0.0%
Gastrointestinal bleeding 0.3% -
Venous thrombosis 0.3% -
Intracranial hemorrhage 0.0% 0.0%
Thrombosis - 0.0%
Embolic event 0.0% 0.0%

Adapted from Blaney M, et al.

*At least 1 due to catheter rupture

  • In COOL-1 and COOL-2, the most serious adverse events reported were sepsis, major hemorrhage, gastrointestinal bleeding, and venous thrombosis. There were no intracranial hemorrhages and no embolic events8
  • In CAPS, sepsis developed in 3 patients; each of these patients had evidence of infection prior to administration of Cathflo and one of them developed fever and lethargy. Four patients experienced catheter-related complications. No pediatric patient experienced an intracranial hemorrhage, major hemorrhage, thrombosis, or embolic event2,8

CAPS=Cathflo Activase Pediatric Study; COOL=Cardiovascular Thrombolytic to Open Occluded Lines.

Learn more about CVAD care and maintenance and FDA-approved dosing and administration of Cathflo here >

NEXT: Learn about the role of central venous access devices (CVADs)
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Important Safety Information

Indication

Cathflo® Activase® (alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.

Contraindications

Cathflo Activase should not be administered to patients with known hypersensitivity to alteplase or any component of the formulation.

Precautions

General

Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase (e.g. catheter malposition, mechanical failure, constriction by a suture and lipid deposits or drug precipitates within the catheter lumen). These types of conditions should be considered before treatment with Cathflo Activase.

Excessive pressure should be avoided when Cathflo Activase is instilled into the catheter. Such force could cause rupture of the catheter or expulsion of the clot into the circulation.

Bleeding

The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding. Cathflo Activase has not been studied in patients known to be at risk for bleeding events that may be associated with the use of thrombolytics. Caution should be exercised with patients who have any condition for which bleeding constitutes a significant hazard.

Should serious bleeding in a critical location (e.g., intracranial, gastrointestinal, retroperitoneal, pericardial) occur, treatment with Cathflo Activase should be stopped and the drug should be withdrawn from the catheter.

Infections

Cathflo Activase should be used with caution in the presence of known or suspected infection in the catheter. Using Cathflo Activase in patients with infected catheters may release a localized infection into the systemic circulation. As with all catheterization procedures, care should be used to maintain aseptic technique.

Hypersensitivity

Hypersensitivity, including urticaria, angioedema and anaphylaxis, has been reported in association with use of Cathflo Activase. Monitor patients treated with Cathflo Activase for signs of hypersensitivity and treat appropriately if necessary.

Drug Interactions and Drug/Laboratory Test Interactions

The interaction of Cathflo Activase with other drugs has not been formally studied. Concomitant use of drugs affecting coagulation and/or platelet function has not been studied.

Potential interactions between Cathflo Activase and laboratory tests have not been studied.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential or the effect on fertility.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Cathflo Activase should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Adverse Reactions

In clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see accompanying full Prescribing Information for additional Important Safety Information.

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