Improvement of hemodialysis catheter function with tenecteplase: a phase III, open-label study: TROPICS 4.
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.
Fishbane
Steven
S
Division of Nephrology, Winthrop-University Hospital, 200 Old Country Rd, #135, Mineola, NY 11501, USA. sfishbane@winthrop.org
Milligan
Samuel L
SL
Lempert
Kenneth D
KD
Hertel
Joachim E W
JE
Wetmore
James B
JB
Oliver
Matthew J
MJ
Blaney
Martha
M
Gillespie
Barbara S
BS
Jacobs
Joan R
JR
Begelman
Susan M
SM
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
D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator; D000077785:Tenecteplase