Abstract

Since there are no antithrombotic dose-response data available for FFR-rFVIIa in humans, we initially proposed to carry out a placebo-controlled, safety and efficacy dose-finding study assessing the effects of dosing FFR-rFVIIa vs placebo in 4 cohorts of patients each (4:1 randomization favoring active therapy) on AVG 111In-platelet deposition at the time of AVG surgical placement or replacement (primary outcome). This dose will subsequently be used in a controlled clinical trial of AVG failure. We also propose to compare the dose-response effects of FFR-rFVIIa vs placebo on post-operative changes in blood tests of thrombosis, tests of hemostasis and measured surgical blood loss (secondary outcome measures).

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000039-39
Application #
6263575
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
39
Fiscal Year
1999
Total Cost
Indirect Cost

  Institution

Name
Emory University
Department
Type
DUNS #
042250712
City
Atlanta
State
GA
Country
United States
Zip Code
30322

  Publications

Yu, Alan S L; Shen, Chengli; Landsittel, Douglas P et al. (2018) Baseline total kidney volume and the rate of kidney growth are associated with chronic kidney disease progression in Autosomal Dominant Polycystic Kidney Disease. Kidney Int 93:691-699
Stevens, Jennifer S; Reddy, Renuka; Kim, Ye Ji et al. (2018) Episodic memory after trauma exposure: Medial temporal lobe function is positively related to re-experiencing and inversely related to negative affect symptoms. Neuroimage Clin 17:650-658
Huang, Yunfeng; Hui, Qin; Walker, Douglas I et al. (2018) Untargeted metabolomics reveals multiple metabolites influencing smoking-related DNA methylation. Epigenomics 10:379-393
Nowak, Kristen L; You, Zhiying; Gitomer, Berenice et al. (2018) Overweight and Obesity Are Predictors of Progression in Early Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol 29:571-578
Lin, Cliff; Michopoulos, Vasiliki; Powers, Abigail et al. (2018) Affect, inflammation, and health in urban at-risk civilians. J Psychiatr Res 104:24-31
Hardy, Raven; Fani, Negar; Jovanovic, Tanja et al. (2018) Food addiction and substance addiction in women: Common clinical characteristics. Appetite 120:367-373
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Logue, Mark W; van Rooij, Sanne J H; Dennis, Emily L et al. (2018) Smaller Hippocampal Volume in Posttraumatic Stress Disorder: A Multisite ENIGMA-PGC Study: Subcortical Volumetry Results From Posttraumatic Stress Disorder Consortia. Biol Psychiatry 83:244-253
McKenzie, Katelyn A; El Ters, Mirelle; Torres, Vicente E et al. (2018) Relationship between caffeine intake and autosomal dominant polycystic kidney disease progression: a retrospective analysis using the CRISP cohort. BMC Nephrol 19:378
Dad, Taimur; Abebe, Kaleab Z; Bae, K Ty et al. (2018) Longitudinal Assessment of Left Ventricular Mass in Autosomal Dominant Polycystic Kidney Disease. Kidney Int Rep 3:619-624

Showing the most recent 10 out of 675 publications