Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran

2015 ◽  
Vol 114 (07) ◽  
pp. 198-205 ◽  
Author(s):  
Paul A. Reilly ◽  
Richard Bernstein ◽  
Robert Dubiel ◽  
John Eikelboom ◽  
Stephan Glund ◽  
...  
Keyword(s):  
Cohort Study ◽  
Healthy Volunteers ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Reversal Agent ◽  
Fab Fragment ◽  
Phase 3 ◽  
Urgent Surgery ◽  
Complete Reversal ◽  
Life Threatening

SummaryIdarucizumab, a Fab fragment directed against dabigatran, produced rapid and complete reversal of the anticoagulation effect of dabigatran in animals and in healthy volunteers. The Study of the REVERS al E ffects of Idarucizumab in Patients on A ctive D abigatran (RE-VERSE AD™) is a global phase 3 prospective cohort study aimed at investigating idarucizumab in dabigatran-treated patients who present with uncontrollable or life-threatening bleeding, and in those requiring urgent surgery or intervention. We describe the rationale for, and design of the trial (clinicaltrials.gov NCT02104947).

scholarly journals Pharmacokinetics of omega-3 fatty acids in patients with severe sepsis compared with healthy volunteers: A prospective cohort study

2020 ◽  
Vol 39 (3) ◽  
pp. 958-965 ◽  
Author(s):  
Radhika Parikh ◽  
Jason H.T. Bates ◽  
Matthew E. Poynter ◽  
Benjamin T. Suratt ◽  
Polly E. Parsons ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Severe Sepsis ◽  
Cohort Study ◽  
Healthy Volunteers ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Omega 3 Fatty Acids ◽  
Omega 3

scholarly journals Life-threatening infections in children in Europe (the EUCLIDS Project): a prospective cohort study

2018 ◽  
Vol 2 (6) ◽  
pp. 404-414 ◽  
Author(s):  
Federico Martinón-Torres ◽  
Antonio Salas ◽  
Irene Rivero-Calle ◽  
Miriam Cebey-López ◽  
Jacobo Pardo-Seco ◽  
...  
Keyword(s):  
Cohort Study ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Life Threatening

Low temperature increases capillary blood refill time following mechanical fingertip compression of healthy volunteers: prospective cohort study

2018 ◽  
Vol 33 (2) ◽  
pp. 259-267 ◽  
Author(s):  
Koichiro Shinozaki ◽  
Michael J. Capilupi ◽  
Kota Saeki ◽  
Hideaki Hirahara ◽  
Katsuyuki Horie ◽  
...  
Keyword(s):  
Cohort Study ◽  
Low Temperature ◽  
Healthy Volunteers ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Capillary Blood

scholarly journals Urgent-start dialysis in patients referred early to a nephrologist—the CKD-REIN prospective cohort study

2021 ◽  
Author(s):  
Victor Fages ◽  
Natalia Alencar de Pinho ◽  
Aghilès Hamroun ◽  
Céline Lange ◽  
Christian Combe ◽  
...  
Keyword(s):  
Cohort Study ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Kidney Injury ◽  
Related Factors ◽  
Post Surgery ◽  
Low Health Literacy ◽  
Lower Egfr ◽  
Life Threatening ◽  
Nationally Representative

Abstract Background The lack of a well-designed prospective study of the determinants of urgent dialysis start led us to investigate its individual- and provider-related factors in patients seeing nephrologists. Methods CKD-REIN is a prospective cohort study that included 3033 patients with CKD (mean age, 67 years; 65% men; mean estimated glomerular filtration rate (eGFR), 32 mL/min/1.73 m2) from 40 nationally representative nephrology clinics from 2013-16, who were followed annually through 2020. Urgent-start dialysis was defined as that “initiated imminently or < 48 hours after presentation to correct life-threatening manifestations” according to KDIGO 2018. Results Over a 4-year (IQR, 3.0-4.8) median follow-up, 541 patients initiated dialysis with a known start status, 86 (16%) urgently. Five-year risks for the competing events of urgent and nonurgent dialysis start, pre-emptive transplantation, and death were 4%, 17%, 3%, and 15%, respectively. Fluid overload, electrolytic disorders, acute kidney injury, and post-surgery kidney function worsening were the reasons most frequently reported for urgent-start dialysis. Adjusted odds ratios (aOR) for urgent start were significantly higher in patients living alone (2.14; 95% CI, 1.08-4.25), or with low health literacy (2.22; 1.28-3.84), heart failure (2.60; 1.47-4.57), or hyperpolypharmacy (taking > 10 drugs) (2.14; 1.17-3.90), but not with age or lower eGFR at initiation. They were lower in patients with planned dialysis modality (0.46; 0.19-1.10) and more nephrologist visits in the 12 months before dialysis (0.81; 0.70-0.94) for each visit. Conclusions This study highlights several patient- and provider-level factors that are important to address to reduce the burden of urgent-start dialysis.

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