title: Improvement of hemodialysis catheter function with tenecteplase: a phase III, open-label study: TROPICS 4.
abstract: Hemodialysis (HD) catheters are prone to thrombotic occlusion. We evaluated tenecteplase, a thrombolytic, for the treatment of dysfunctional HD catheters. Patients with tunneled HD catheters and blood flow rate (BFR) <300 mL/min received open-label tenecteplase (2 mg/lumen) for a 1 h intracatheter dwell. Treatment success was defined as BFR ≥ 300 mL/min and a ≥ 25 mL/min increase from baseline BFR, 30 min before and at the end of HD. Patients without treatment success at the end of the initial visit received another 2 mg dose of tenecteplase for an up to 72 h extended dwell. Of 223 enrolled patients, 34% (95% confidence interval [CI], 28-40%) had treatment success after a 1 h dwell. Mean (standard deviation [SD]) BFR change from baseline was 82 (124) mL/min. Treatment success in those who received extended-dwell tenecteplase (n = 116) was 49% (95% CI, 40-58%), with mean (SD) BFR change from baseline of 117 (140) mL/min. Reported targeted adverse events included five catheter-related bloodstream infections and one thrombosis. No intracranial hemorrhage, major bleeding, embolic events, or catheter-related complications were reported. Tenecteplase administered as a 1 h or 1 h plus extended dwell was associated with improved HD catheter function in the TROPICS 4 trial.
authors.affiliation: Division of Nephrology, Winthrop-University Hospital, 200 Old Country Rd, #135, Mineola, NY 11501, USA. sfishbane@winthrop.org
authors.forename: Steven
authors.initials: S
authors.lastname: Fishbane
authors.forename: Samuel L
authors.initials: SL
authors.lastname: Milligan
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Lempert
authors.forename: Joachim E W
authors.initials: JE
authors.lastname: Hertel
authors.forename: James B
authors.initials: JB
authors.lastname: Wetmore
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Oliver
authors.forename: Martha
authors.initials: M
authors.lastname: Blaney
authors.forename: Barbara S
authors.initials: BS
authors.lastname: Gillespie
authors.forename: Joan R
authors.initials: JR
authors.lastname: Jacobs
authors.forename: Susan M
authors.initials: SM
authors.lastname: Begelman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D057785:Catheters; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis / Q000379:methods*; D000077785:Tenecteplase; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator; D000077785:Tenecteplase