Search Results - "Alexander, W Allan"

Safety and Immunogenicity Observations Pooled from Eight Clinical Trials of Recombinant Human Thrombin by Ballard, Jeffrey L., MD, FACS, Weaver, Fred A., MD, FACS, Singla, Neil K., MD, Chapman, William C., MD, FACS, Alexander, W. Allan, MD

“…Background We evaluated safety and immunogenicity observations pooled from 8 clinical trials of recombinant human thrombin (rThrombin), an active topical…”
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Immunogenicity and Safety of Re-Exposure to Recombinant Human Thrombin in Surgical Hemostasis by Singla, Neil K., MD, Gasparis, Antonios P., MD, FACS, Ballard, Jeffrey L., MD, FACS, Baron, Jeffrey M., MD, Butine, Michael D., PhD, Pribble, John P., PharmD, Alexander, W. Allan, MD

“…Background This Phase 4, open-label study evaluated the immunogenicity and safety of a second exposure to recombinant human thrombin (rThrombin) in adult…”
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Safety and Immunogenicity of Recombinant Human Thrombin: A Pooled Analysis of Results from 10 Clinical Trials by Singla, Neil K., Foster, Kevin N., Alexander, W. Allan, Pribble, John P.

“…Study Objective To evaluate the safety and immunogenicity of recombinant human thrombin (rThrombin), an active topical stand‐alone hemostatic agent. Design…”
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A comparison of recombinant thrombin to bovine thrombin as a hemostatic ancillary in patients undergoing peripheral arterial bypass and arteriovenous graft procedures by Weaver, Fred A., MD, Lew, Wesley, MD, Granke, Kenneth, MD, Yonehiro, Layne, MD, Delange, Burke, MD, Alexander, W. Allan, MD

“…Objectives Recombinant thrombin (rThrombin) is a potential hemostatic alternative to bovine and human plasma-derived thrombin. This report examines the…”
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Persistence of Antibodies to the Topical Hemostat Bovine Thrombin by Randleman, C. Duane, MD, Singla, Neil K., MD, Renkens, Kenneth L., MD, FACS, Souza, Sonia, PhD, Pribble, John P., PharmD, Alexander, W. Allan, MD

“…Background Immunoassays that detect antibovine thrombin product antibodies are not widely available. However, knowing whether these antibodies are present…”
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Characterization of a canine freeze-dried platelet-derived hemostatic agent: A preclinical model for surgical and traumatic hemorrhage by Brown, Meredith, Kuhn, Benjamin, Moskowitz, Keith A., Amos, Stephen, Mays, Erin Long, Alexander, W. Allan, Fitzpatrick, G. Michael

“…A freeze-dried, platelet-derived hemostatic agent (FPH) was developed for acute hemorrhage. The canine product (cFPH) was developed for use in preclinical…”
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Mechanisms of action of an investigational new freeze-dried platelet-derived hemostatic product by Kuhn, Benjamin J., Swanson, Ana, Cherupalla, Arjun S., Booth, Lisa, Dickerson, W. Matthew, Fitzpatrick, G. Michael, Alexander, W. Allan, Moskowitz, Keith A.

“…A safe and efficacious hemostatic product with a long shelf-life is needed to reduce mortality from hemorrhage due to trauma and improve surgical outcomes for…”
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A Phase 3b, Open-Label, Single-Group Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis by Singla, Neil K., MD, Ballard, Jeffrey L., MD, FACS, Moneta, Gregory, MD, FACS, Randleman, C. Duane, MD, Renkens, Kenneth L., MD, FACS, Alexander, W. Allan, MD

“…Background The immunogenicity and safety of recombinant human thrombin (rThrombin) were evaluated in this phase 3b, open-label, single-group, multisite study…”
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Bleeding in patients with hemophilia who have inhibitors: Modeling US medical system utilization and cost avoidance between recombinant factor VIIa products with different clinical dosing requirements by Alexander, W. Allan, Jensen, Ivar, Hathway, Joanne, Srivastava, Krutika, Cyr, Philip, Sidonio, Robert F, Batt, Katharine

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The safety of activated eptacog beta in the management of bleeding episodes and perioperative haemostasis in adult and paediatric haemophilia patients with inhibitors by Escobar, Miguel, Castaman, Giancarlo, Boix, Santiago Bonanad, Callaghan, Michael, Moerloose, Philippe, Ducore, Jonathan, Hermans, Cédric, Journeycake, Janna, Leissinger, Cindy, Luck, James, Mahlangu, Johnny, Miesbach, Wolfgang, Mitha, Ismail Haroon, Négrier, Claude, Quon, Doris, Recht, Michael, Schved, Jean François, Shapiro, Amy D., Sidonio, Robert, Srivastava, Alok, Stasyshyn, Oleksandra, Vilchevska, Kateryna V., Wang, Michael, Young, Guy, Alexander, W. Allan, Al‐Sabbagh, Ahmad, Bonzo, Daniel, Macie, Christopher, Wilkinson, Thomas A., Kessler, Craig

“…Introduction Haemophilia patients with inhibitors often require a bypassing agent (BPA) for bleeding episode management. Eptacog beta (EB) is a new…”
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PERSEPT 3: A phase 3 clinical trial to evaluate the haemostatic efficacy of eptacog beta (recombinant human FVIIa) in perioperative care in subjects with haemophilia A or B with inhibitors by Escobar, Miguel, Luck, James, Averianov, Yevhenii, Ducore, Jonathan, Fernández, Maria Fernanda López, Giermasz, Adam, Hart, Daniel P., Journeycake, Janna, Kessler, Craig, Leissinger, Cindy, Mahlangu, Johnny, Martinez, Laura Villarreal, Miesbach, Wolfgang, Mitha, Ismail Haroon, Quon, Doris, Reding, Mark T., Schved, Jean‐François, Stasyshyn, Oleksandra, Vilchevska, Kateryna V., Wang, Michael, Windyga, Jerzy, Alexander, W. Allan, Al‐Sabbagh, Ahmad, Bonzo, Daniel, Mitchell, Ian S., Wilkinson, Thomas A., Hermans, Cédric

“…Introduction Surgical procedures in persons with haemophilia A or B with inhibitors (PwHABI) require the use of bypassing agents (BPA) and carry a high risk of…”
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Eptacog beta efficacy and safety in the treatment and control of bleeding in paediatric subjects (<12 years) with haemophilia A or B with inhibitors by Pipe, Steven W., Hermans, Cédric, Chitlur, Meera, Carcao, Manuel, Castaman, Giancarlo, Davis, Joanna A., Ducore, Jonathan, Dunn, Amy L., Escobar, Miguel, Journeycake, Janna, Khan, Osman, Mahlangu, Johnny, Meeks, Shannon L., Mitha, Ismail Haroon, Négrier, Claude, Nowak‐Göttl, Ulrike, Recht, Michael, Chrisentery‐Singleton, Tammuella, Stasyshyn, Oleksandra, Vilchevska, Kateryna V., Martinez, Laura Villarreal, Wang, Michael, Windyga, Jerzy, Young, Guy, Alexander, W. Allan, Bonzo, Daniel, Macie, Christopher, Mitchell, Ian S., Sauty, Evelyne, Wilkinson, Thomas A., Shapiro, Amy D.

“…Introduction Eptacog beta is a new recombinant activated human factor VII bypassing agent approved in the United States for the treatment and control of…”
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Recombinant human thrombin: safety and immunogenicity in pediatric burn wound excision by Foster, Kevin N, Mullins, R. Fred, Greenhalgh, David G, Gamelli, Richard L, Glat, Paul, Lentz, Christopher W, Kahn, Steven A, Brandigi, Claus, Fredlund, Paul, Alexander, W. Allan

“…Abstract Background Previous studies of recombinant human thrombin (rThrombin) enrolled adult and adolescent patients. This phase 4, open-label, single-group…”
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Recombinant Thrombin: Safety and Immunogenicity in Burn Wound Excision and Grafting by GREENHALGH, David G, GAMELLI, Richard L, COLLINS, Jay, SOOD, Rajiv, MOZINGO, David W, GRAY, Todd E, ALEXANDER, W. Allan

“…This study evaluated the safety, immunogenicity, and hemostatic effect of recombinant human Thrombin (rThrombin), in patients undergoing skin grafting for…”
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Topical recombinant thrombin at a concentration of 1000 IU/mL reliably shortens in vivo TTH and delivers durable hemostasis in the presence of heparin anticoagulation and clopidogrel platelet inhibition in a rabbit model of vascular bleeding by Hughes, Steven D, Bishop, Paul D, Garcia, Richard, Zhang, Tracy, Alexander, W Allan

“…This study was designed to evaluate the effect of recombinant human thrombin (rThrombin) concentration on time to hemostasis (TTH), clot durability, and clot…”
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Building an immune-mediated coagulopathy consensus: early recognition and evaluation to enhance post-surgical patient safety by Ness, Paul, Creer, Michael, Rodgers, George M, Naoum, Joseph J, Renkens, Kenneth, Voils, Stacy A, Alexander, W Allan

“…Topical hemostats, fibrin sealants, and surgical adhesives are regularly used in a variety of surgical procedures involving multiple disciplines. Generally,…”
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PERSEPT3: A Phase 3 Clinical Trial to Evaluate the Hemostatic Efficacy of Eptacog Beta (Recombinant Human FVIIa) in Perioperative Care in Subjects with Hemophilia Α or B with Inhibitors by Escobar, Miguel A., Quon, Doris, Leissinger, Cindy A., Luck, James V, Al-Sabbagh, Ahmad, Bonzo, Daniel, Mitchell, Ian S, Alexander, W Allan, Hermans, Cedric

“…Introduction Eptacog beta [Sevenfact®, coagulation factor VIIa (recombinant)-jncw] (HEMA Biologics and LFB) is a human rFVIIa variant indicated for the…”
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Single 225μg/Kg Dose Treatment with Eptacog Beta (Factor VIIa, Recombinant) Results in Rapid Hemostasis in Joint Bleeds for Persons with Hemophilia Α or Β with Inhibitors: A PERSEPT1 Subset Analysis by Journeycake, Janna M., Hermans, Cedric, Ducore, Jonathan M., Escobar, Miguel A., Young, Guy, Wang, Michael, Quon, Doris, Alexander, W Allan, Mitchell, Ian S, Al-Sabbagh, Ahmad, Bonzo, Daniel

“…Introduction Joint bleeding events (BEs) have cumulative, irreversible and debilitating consequences for persons with hemophilia A or B with inhibitors…”
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Athn 16: Safety of Coagulation Factor VIIa (recombinant)-Jncw for the Treatment of Bleeding Events in Patients with Congenital Hemophilia a or B with Inhibitors with or without Prophylactic Treatment by Chrisentery-Singleton, Tammuella, Alexander, W Allan, Al-Sabbagh, Ahmad, Bonzo, Daniel, Callaghan, Michael U., Escobar, Miguel A., Giermasz, Adam, Hirsh, Nikki, Journeycake, Janna, Nasr, Sonia, Quon, Doris V., Recht, Michael

“…Background: A new recombinant activated factor VII, eptacog beta (SEVENFACT®, rFVIIa-jncw) has been approved by the U.S. Food and Drug Administration (FDA) for…”
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Eptacog Beta Efficacy in Children and Adolescents with Hemophilia A or B and Inhibitors: Subset Analysis Suggests Improved Caregiver Capacity to Assess Bleeding Episode Resolution with Subject Age by Young, Guy, Pipe, Steven W, Hermans, Cédric, Carcao, Manuel, Castaman, Giancarlo, Davis, Joanna A., Ducore, Jonathan M., Dunn, Amy L., Escobar, Miguel A., Journeycake, Janna, Khan, Osman, Mahlangu, Johnny, Meeks, Shannon, Mitha, Ismail Haroon, Négrier, Claude, Nowak-Göttl, Ulrike, Recht, Michael, Chrisentery-Singleton, Tammuella, Stasyshyn, Oleksandra, Vilchevska, Kateryna V., Villarreal Martinez, Laura, Wang, Michael, Windyga, Jerzy, Alexander, W. Allan, Al-Sabbagh, Ahmad, Bonzo, Daniel, Macie, Christopher, Mitchell, Ian S., Wilkinson, Thomas A., Shapiro, Amy D.

“…Introduction Following treatment with a bypassing agent, parents or caregivers often face difficulties in determining bleeding episode (BE) resolution in…”
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