NCT00395876 - A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters | Crick

Overview

This was a Phase III, randomized, double-blind, placebo-controlled study that was conducted at 24 centers in the United States and Canada. 100 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were randomly assigned in a 1:1 ratio to receive an initial dose of either placebo (Arm A) or tenecteplase (Arm B).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Dysfunctional Central Venous Access Catheters

Interventions

placeboDRUG

2 mL of placebo instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of placebo). Patients weighing \< 30 kg received instillations of study drug equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg).

tenecteplaseDRUG

2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of tenecteplase). Patients weighing \< 30 kg received instillations of study drug equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg).

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Clinically stable, in the opinion of the investigator * CVC occlusion * Able to have fluids infused at the volume necessary to instill study drug into the CVC Exclusion Criteria: * Able to have 3 mL of blood (patients weighing ≥ 10 kg) or 1 mL of blood (patients weighing \< 10 kg) withdrawn from the selected study CVC following patient repositioning * Selected study CVC inserted \< 2 days prior to treatment * Selected study CVC known to be dysfunctional for \> 7 days * Selected study CVC implanted specifically for hemodialysis (HD) * Use of a power injector on the selected study CVC during the study * Evidence of mechanical, non-thrombotic occlusion of the selected study CVC (e.g., kink in the catheter or suture constricting the catheter) * Previously treated in this study or any tenecteplase catheter clearance trial * Use of any investigational drug or therapy within 28 days prior to treatment * Use of a fibrinolytic agent (e.g., alteplase, tenecteplase, reteplase, or urokinase) within 24 hours prior to treatment * Known to be pregnant or breastfeeding at screening * CVC with known or suspected infection * History of any intracranial hemorrhage, aneurysm, or arteriovenous malformation * Use of heparin (unfractionated or low molecular weight) within 24 hours prior to treatment, except for use of intermittent or low-dose, continuous infusion of heparin to maintain catheter or vessel patency * Use of warfarin within 7 days prior to treatment, except for low-dose warfarin used for prophylaxis * Initiation of or increase in dose of Plavix® (clopidogrel bisulfate) within 7 days prior to treatment * At high risk for bleeding events or embolic complications (i.e., recent pulmonary embolus, deep vein thrombosis, endarterectomy, or clinically significant right-to-left shunt) in the opinion of the investigator, or with known condition for which bleeding constitutes a significant hazard * Known hypersensitivity to tenecteplase or any component of the formulation

Outcomes

Primary Outcomes

Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug

Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.

Time frame: 120 minutes after first dose

Secondary Outcomes

Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug

Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.

Time frame: 15 minutes after first dose

Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug

Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.

Time frame: 30 minutes after first dose

Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug

Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.

Time frame: 15 minutes after second dose

Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug