Conditions: Dysfunctional Central Venous Access Catheters
Keywords: TNKase CVA CVAD Central venous access catheter
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 251
Healthy volunteers: no

Brief summary:
This was a Phase III, open-label, single-arm study that was conducted at 43 centers in the United States and Canada. 251 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were enrolled in the study and treated with one or two doses of tenecteplase.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: tenecteplase
Intervention descriptions: intervention 1: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.

Patients weighing ≥ 30 kg received 2-mL instillations of tenecteplase (i.e., 2 mg of tenecteplase). Patients weighing \< 30 kg received instillations of tenecteplase 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).

Protocol document: