Pivotal Phase III Study: Safety of Polymerized Bovine Hemoglobin (HBOC-201, Hemopure®) as Compared to RBC in Patients Undergoing Orthopedic Surgery

Jahr, J. S.; Stewart, Lauraine M.; MacKenzie, C. N.; Bourke, Denis L.; Williams, John P.

doi:10.1097/00000542-200209002-00243

Cited by 17 publications

(12 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Similar to the studies above, transient increases in blood pressure were observed in the HBOC group, but they were not associated with any clinical sequelae. Adverse events occurring more frequently in the HBOC group also included gastrointestinal and cutaneous events, but these events were mild and self-limited [10]. The two groups had comparable mortality and serious-adverse-event rates.…”

Section: Hboc In Orthopaedic Patientsmentioning

confidence: 94%

“…The safety and efficacy of HBOC-201 was evaluated in patients undergoing orthopaedic surgery in a Phase III study [10]. In this single-blind, multicenter randomized study of 688 patients who underwent orthopaedic procedures and subsequently needed a blood transfusion, 350 patients received HBOC-201 and 338 received allogeneic blood transfusion.…”

Section: Hboc In Orthopaedic Patientsmentioning

confidence: 99%

See 1 more Smart Citation

Hemoglobin substitutes

2004

View full text Add to dashboard Cite

Section: Hboc In Orthopaedic Patientsmentioning

confidence: 94%

Section: Hboc In Orthopaedic Patientsmentioning

confidence: 99%

Hemoglobin substitutes

2004

View full text Add to dashboard Cite

“…In April 2001, Hemopure was approved for use in South Africa for acute anemia in surgery patients, and it is the first HBOC approved for human use. Biopure Corporation has recently described the safety and efficacy results of its phase 3 clinical trials [35][36][37]. Baxter has discontinued clinical trials on DLCHb (HemeAssist), as has Hemosol 328 Drugs in anaesthesia Outlook of blood substitutes as pharmacotherapies for the future…”

Section: Adverse Effects Of Hemoglobin-based Oxygen Carriers and Perfmentioning

confidence: 99%

Blood substitutes as pharmacotherapies in clinical practice

Jahr

Walker²,

Manoochehri³

2007

Current Opinion in Anaesthesiology

View full text Add to dashboard Cite

Polymerized hemoglobin preparations have proven most successful in clinical trials due to their improved side-effect profile. The goal is to evaluate blood substitutes with enhanced intravascular retention, reduced osmotic activity, and attenuated hemodynamic derangements such as vasoconstriction. Although not without substantial morbidity and mortality, the current safety of allogeneic blood transfusion demands that comparative studies show minimal adverse effects, as well as efficacy and potential for novel applications.

show abstract

“…Adverse and serious adverse events of 688 out of 693 patients enrolled into the study were reported in another abstract [104]. In HBOC-201 treated patients more adverse and serious adverse events were reported.…”

Section: Polymerized Bovine Hemoglobin-based O2 Carrier (Hboc-201)mentioning

confidence: 99%

Artificial O2 Carriers: Status in 2005

Spahn¹,

Kocián²

2005

CPD

View full text Add to dashboard Cite

Donor blood is a limited resource and its transfusion is associated with significant adverse effects. Therefore, alternatives have been searched, the ultimate being artificial oxygen (O2) carriers. There are two main groups of artificial O2 carriers: hemoglobin based and perfluorocarbon emulsions. The hemoglobin molecule in hemoglobin based artificial O2 carriers needs to be stabilized to prevent dissociation of the alpha2beta2-hemoglobin tetramer into alphabeta-dimers in order to prolong intravascular retention and to eliminate nephrotoxicity. Other modifications serve to decrease O2 affinity in order to improve O2 off-loading to tissues. In addition, polyethylene glycol may be surface conjugated to increase molecular size. Finally, certain products are polymerized to increase the hemoglobin concentration at physiologic colloid oncotic pressure. Perfluorocarbons are carbon-fluorine compounds characterized by a high gas dissolving capacity for O2 and CO2 and chemical and biologic inertness. Perfluorocarbons are not miscible with water and therefore need to be brought into emulsion for intravenous application. Development, product specification, physiologic effects, efficacy to decrease the need for donor blood in surgery and side effects of the following products are described: Diaspirin cross-linked hemoglobin (HemAssist), human recombinant hemoglobin (rHb1.1 and rHb2.0), polymerized bovine hemoglobin-based O2 carrier (HBOC-201), human polymerized hemoglobin (PolyHeme), hemoglobin raffimer (Hemolink), maleimide-activated polyethylene glycol-modified hemoglobin (MP4) and perflubron emulsion (Oxygent). In addition, enzyme cross-linked poly-hemoglobin, hemoglobin containing vesicles (nano-dimension artificial red blood cells) and an allosteric modifier (RSR13) are discussed. The most advanced products are in clinical phase III trials but no product has achieved market approval yet in the US, Europe or Canada.

show abstract

Pivotal Phase III Study: Safety of Polymerized Bovine Hemoglobin (HBOC-201, Hemopure®) as Compared to RBC in Patients Undergoing Orthopedic Surgery

Cited by 17 publications

References 0 publications

Hemoglobin substitutes

Hemoglobin substitutes

Blood substitutes as pharmacotherapies in clinical practice

Artificial O2 Carriers: Status in 2005

Contact Info

Product

Resources

About