50
Participants
Start Date
May 14, 2020
Primary Completion Date
March 21, 2021
Study Completion Date
September 30, 2021
Alteplase 50 MG [Activase]
Patients randomized to Alteplase-50 group will receive 50 mg of Alteplase intravenous bolus administration over 2 hours, given as a 10 mg push followed by the remaining 40 mgs over a total time of 2 hrs. Immediately following the Alteplase infusion, 5000 units (U) of unfractionated heparin (UFH) will be delivered and the heparin drip will be continued to maintain the activated partial thromboplastin time (aPTT) at 60-80sec (2.0 to 2.5 times the upper limit of normal). Re-bolusing of Alteplase, at the same dose, is permitted in the Alteplase-50 intervention group in those patients who show an initial transient response (\>20% improvement of PaO2/FiO2 over pre-infusion of Alteplase at any of the measurements at 2, 6, 12 or 18 hours, but \<50% improvement of PaO2/FiO2 at 24 hours after randomization); the repeat dose will be given between 24 and 36 hours after the initial Alteplase administration.
Alteplase 50 MG [Activase]
wed by the remaining 40 mgs over a total time of 2 hrs. Immediately following this initial Alteplase infusion, we will initiate a drip of 2 mg/hr Alteplase over the ensuing 24 hours (total 48 mg infusion) accompanied by an infusion of 500 units per hour (U/hr) heparin during the Alteplase drip. After this, heparin dose will be increased slowly to maintain aPTT between 60 and 80 sec, titrated per attending's discretion.
Long Island Jewish Medical Center, New York
St. Mary's Medical Center, West Palm Beach
Methodist Dallas Medical Center, Dallas
Ben Taub Hospital, Houston
University of Colorado, Denver, Aurora
Denver Health Medical Center, Denver
National Jewish Health, Denver
Scripps Memorial Hospital La Jolla, La Jolla
Beth Israel Deaconess Medical Center, Boston
Collaborators (1)
Genentech, Inc.
INDUSTRY
University of Colorado, Denver
OTHER
National Jewish Health
OTHER
Beth Israel Deaconess Medical Center
OTHER
Long Island Jewish Medical Center
OTHER
Scripps Health
OTHER
St. Mary's Medical Center
OTHER
University of Miami
OTHER
Ben Taub Hospital
OTHER
The Methodist Hospital Research Institute
OTHER
Denver Health and Hospital Authority
OTHER