Phase III Study of Hemospan® for Treating Hypotension in Hip Arthroplasty
NCT ID: NCT00420277
Last Updated: 2013-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
462 participants
INTERVENTIONAL
2007-02-28
2008-04-30
Brief Summary
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Detailed Description
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Spinal anesthesia is the preferred choice for hip arthroplasty procedures in elderly patients, but is associated with a functional hypovolemia due to loss of vascular tone that frequently causes acute hypotensive episodes. Hypotension represents a surrogate marker of hypovolemia that may be further exacerbated by surgical bleeding, which can result in decreased cardiac output, insufficient perfusion and inadequate tissue oxygenation. Ischemia resulting from hypotension can adversely affect vital organ function and may result in complications and postoperative morbidity. As the population ages and more patients become candidates for orthopedic reconstruction or joint replacement surgery, the number of patients at risk is increasing. The ideal IV solution for treating hypovolemia-associated hypotension and improving hemodynamic stability would be an effective plasma expander that promotes tissue perfusion and delivers oxygen to ischemic or marginally hypoxic tissue.
Preclinical animal studies have shown that Hemospan may be well-suited to this application and may even be better than blood in some situations. Data from Sangart's Phase II orthopedic surgery study (No. 6055), published recently by Olofsson et al. (Anesthesiology 2006; 105(6):1153-63) support the safety and potential benefit of Hemospan for preventing and treating hypotension in orthopedic surgery patients undergoing hip replacement surgery under spinal anesthesia.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Hemospan (MP4OX)
4.3 g/dL MalPEG-Hb solution
Hemospan (MP4OX)
250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers
Control
Voluven (HES 130/0.4)
Voluven (HES 130/0.4)
250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers
Interventions
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Hemospan (MP4OX)
250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers
Voluven (HES 130/0.4)
250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult male or female (surgically sterile or post-menopausal), aged 50 years or older
* American Society of Anesthesiology (ASA) Class II or III
* Physical examination, laboratory status, vital signs, and ECG within acceptable limits for the planned surgery, as judged by the investigator
* Have been given written and verbal information by the investigator about Hemospan and the protocol, and have had the opportunity to ask questions about the study
* Patients must sign an Informed Consent form that has been reviewed and approved by the independent Ethics Committee
Exclusion Criteria
* Clinical evidence of uncontrolled cardiovascular, infectious, psychiatric, metabolic or systemic disorders including diabetes and rheumatoid arthritis
* Evidence of significant hypertension with SBP \>180 mmHg, or a difference in SBP obtained in each arm that is \>15 mmHg (measured in the supine position in both arms, at screening)
* Recent history or evidence of MI or stroke (within 6 months)
* Known alcohol or drug dependency
* Currently taking oral anti-coagulant therapy; except for low-dose aspirin (acetylsalicylic acid), \<200 mg/day
* History of coagulopathy
* Involved in any investigational drug or device trial within 30 days prior to this study
* Professional or ancillary personnel involved with this study
50 Years
ALL
No
Sponsors
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Sangart
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe van der Linden, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHU Brugmann, Brussels
Locations
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CHU Brugmann
Brussels, , Belgium
Z.O.L. Genk
Genk, , Belgium
Stedelijk Ziekenhuis Roeselare
Roeselare, , Belgium
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice Motol, I. Ortopedicka klinika
Prague, , Czechia
Fakultni nemocnice Motol, II. Ortopedicka klinika
Prague, , Czechia
Fakultni nemocnice Na Bulovce
Prague, , Czechia
Medisch Spectrum Twente
Enschede, , Netherlands
Tergooi Ziekenhuizen, locatie Hilversum
Hilversum, , Netherlands
Sint Maartenskliniek
Nijmegen, , Netherlands
UMC Erasmus
Rotterdam, , Netherlands
Samodzielny Publiczny Szpital Kliniczny AM
Bialystok, , Poland
SP Wojewódzki Szpital Chirurgii Urazowej
Piekary Śląskie, , Poland
Wojewódzki Szpital Specjalistyczny nr 5
Sosnowiec, , Poland
Instytut Reumatologii, Klinika Reumoortopedii
Warsaw, , Poland
SK Dzieciątka Jezus
Warsaw, , Poland
Länssjukhuset Gävle
Gävle, , Sweden
Kalmar Hospital
Kalmar, , Sweden
Lasarettet Motala
Motala, , Sweden
Danderyd Sjukhus
Stockholm, , Sweden
Söder Hospital
Stockholm, , Sweden
Uddevalla Sjukhus
Uddevalla, , Sweden
Countries
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References
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Bjorkholm M, Fagrell B, Przybelski R, Winslow N, Young M, Winslow RM. A phase I single blind clinical trial of a new oxygen transport agent (MP4), human hemoglobin modified with maleimide-activated polyethylene glycol. Haematologica. 2005 Apr;90(4):505-15.
Cabrales P, Tsai AG, Winslow RM, Intaglietta M. Effects of extreme hemodilution with hemoglobin-based O2 carriers on microvascular pressure. Am J Physiol Heart Circ Physiol. 2005 May;288(5):H2146-53. doi: 10.1152/ajpheart.00749.2004. Epub 2005 Jan 6.
Young MA, Riddez L, Kjellstrom BT, Bursell J, Winslow F, Lohman J, Winslow RM. MalPEG-hemoglobin (MP4) improves hemodynamics, acid-base status, and survival after uncontrolled hemorrhage in anesthetized swine. Crit Care Med. 2005 Aug;33(8):1794-804. doi: 10.1097/01.ccm.0000172648.55309.13.
Tsai AG, Cabrales P, Manjula BN, Acharya SA, Winslow RM, Intaglietta M. Dissociation of local nitric oxide concentration and vasoconstriction in the presence of cell-free hemoglobin oxygen carriers. Blood. 2006 Nov 15;108(10):3603-10. doi: 10.1182/blood-2006-02-005272. Epub 2006 Jul 20.
Winslow RM. Current status of oxygen carriers ('blood substitutes'): 2006. Vox Sang. 2006 Aug;91(2):102-10. doi: 10.1111/j.1423-0410.2006.00789.x.
Olofsson C, Ahl T, Johansson T, Larsson S, Nellgard P, Ponzer S, Fagrell B, Przybelski R, Keipert P, Winslow N, Winslow RM. A multicenter clinical study of the safety and activity of maleimide-polyethylene glycol-modified Hemoglobin (Hemospan) in patients undergoing major orthopedic surgery. Anesthesiology. 2006 Dec;105(6):1153-63. doi: 10.1097/00000542-200612000-00015.
Winslow RM. Red cell substitutes. Semin Hematol. 2007 Jan;44(1):51-9. doi: 10.1053/j.seminhematol.2006.09.013.
van der Linden P, Gazdzik TS, Jahoda D, Heylen RJ, Skowronski JC, Pellar D, Kofranek I, Gorecki AZ, Fagrell B, Keipert PE, Hardiman YJ, Levy H; 6090 Study Investigators. A double-blind, randomized, multicenter study of MP4OX for treatment of perioperative hypotension in patients undergoing primary hip arthroplasty under spinal anesthesia. Anesth Analg. 2011 Apr;112(4):759-73. doi: 10.1213/ANE.0b013e31820c7b5f. Epub 2011 Feb 11.
Related Links
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Click here for more information about Sangart, Inc.
Other Identifiers
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6090
Identifier Type: -
Identifier Source: org_study_id