Phase I study of the safety and pharmacologic effects of diaspirin cross-linked hemoglobin solution

Critical Care Medicine
R J PrzybelskiW A Colburn

Abstract

To evaluate the safety, pharmacokinetics, and pharmacodynamics of diaspirin cross-linked hemoglobin solution (DCLHb) in normal, healthy volunteers. Randomized, double-blind, controlled, crossover study. Phase I research facility of a contract research organization. Twenty-four healthy adult volunteers. Diaspirin cross-linked hemoglobin solution (25, 50, or 100 mg/kg) or equal volume of lactated Ringer's solution was infused on day 1; the alternate solution was infused 6 days later. Laboratory analyses, electrocardiograms, and Holter and telemetry monitoring were performed to assess organ function, pharmacokinetics, and potential toxicity. Vital signs, pulse oximetry, laser Doppler flowmetry, and toe temperature were measured to evaluate diaspirin cross-linked hemoglobin solution's pharmacodynamic effects. There were no serious adverse events associated with diaspirin cross-linked hemoglobin solution infusion. Abdominal pain occurred in three subjects after control infusion and in six subjects after diaspirin cross-linked hemoglobin solution infusion; no treatment was required. A dose-related increase in lactic dehydrogenase (LDH)-5 isoenzyme concentrations was observed in 12 subjects after diaspirin cross-linked hemoglobin solu...Continue Reading

References

Jan 1, 1978·Clinical Pharmacology and Therapeutics·J P SavitskyJ D Arnold
Apr 1, 1991·Journal of Applied Physiology·J R HessR M Winslow
May 1, 1995·Critical Care Medicine·C C PowellD S Malcolm
Jan 1, 1994·Artificial Cells, Blood Substitutes, and Immobilization Biotechnology·D NolteK Messmer
Jan 1, 1994·Artificial Cells, Blood Substitutes, and Immobilization Biotechnology·A C SharmaA Gulati
Jan 1, 1994·Artificial Cells, Blood Substitutes, and Immobilization Biotechnology·D S MalcolmK Burhop
Dec 1, 1995·The American Journal of Physiology·L Smith, J B Smith

❮ Previous
Next ❯

Citations

Jun 6, 2000·Advanced Drug Delivery Reviews·D R Spahn
Jun 6, 2000·Advanced Drug Delivery Reviews·R PalaparthyA Gulati
Mar 10, 2001·Transfusion·C P StowellR M Winslow
Feb 6, 2004·The New England Journal of Medicine·Peter HillmenRussell P Rother
Nov 19, 2004·Antioxidants & Redox Signaling·Ann L Baldwin
Feb 23, 2010·Antioxidants & Redox Signaling·Brandon J Reeder
Aug 31, 2000·Critical Care Medicine·J CreteurJ L Vincent
May 4, 2002·The Journal of Trauma·Edward P SloanUNKNOWN DCLHb Traumatic Hemorrhagic Shock Study Group
Oct 24, 2002·Current Opinion in Hematology·Christopher P Stowell
Jan 16, 2004·Critical Care Medicine·Jacques Creteur, Jean-Louis Vincent
May 17, 2005·American Journal of Physiology. Heart and Circulatory Physiology·Kenji SampeiRaymond C Koehler
Jul 21, 2001·American Journal of Respiratory and Critical Care Medicine·B D FreemanC Natanson
Nov 19, 2005·The Journal of Clinical Investigation·Peter C MinneciSteven B Solomon
Mar 27, 2003·Sports Medicine·Aurelie GaudardMichel Audran
Feb 28, 2004·Sports Medicine·Yorck Olaf Schumacher, Michael Ashenden
Dec 1, 2001·Expert Opinion on Biological Therapy·T Standl
Nov 4, 2000·Expert Opinion on Investigational Drugs·K D Vandegriff
May 5, 2007·Expert Opinion on Biological Therapy·Abdu I AlayashPaul W Buehler
May 5, 1999·Artificial Cells, Blood Substitutes, and Immobilization Biotechnology·W SeftonS Muldoon
Feb 7, 1998·Annals of Medicine·S M Cohn
Apr 4, 2009·Critical Care Clinics·Jacques Creteur, Jean-Louis Vincent
Feb 26, 2008·Transfusion clinique et biologique : journal de la Société française de transfusion sanguine·Y SmaniB Faivre
Jun 5, 2007·Translational Research : the Journal of Laboratory and Clinical Medicine·Mark A YoungRobert M Winslow
Nov 12, 2009·Transfusion·Toby A Silverman, Richard B Weiskopf
Apr 6, 2007·British Journal of Haematology·Anita HillPeter Hillmen
Dec 9, 1998·Artificial Cells, Blood Substitutes, and Immobilization Biotechnology·L T WongF J Carmichael
Oct 1, 1998·Biochemical and Biophysical Research Communications·T TalaricoC Privalle
Mar 29, 2001·The Journal of Pharmacy and Pharmacology·R PalaparthyA Gulati
Oct 28, 2009·Anesthesiology·Toby A SilvermanUNKNOWN Planning Committee and the Speakers
Aug 5, 2000·ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs·X M MuellerL K von Segesser
Nov 1, 2016·Artificial Cells, Nanomedicine, and Biotechnology·Alexandre Fabricio MartucciYara Marcondes Machado Castiglia
Mar 25, 2017·Journal of Functional Biomaterials·Kazuaki TaguchiMasaki Otagiri
May 29, 1999·AACN Clinical Issues·J Mikhail
Apr 1, 1997·The Journal of Trauma·S M Cohn
Aug 2, 2000·Critical Care Medicine·F J CarmichaelA G Greenburg

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.