Phase III Study of Hemospan® for Treating Hypotension in Hip Arthroplasty
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| ClinicalTrials.gov Identifier: NCT00420277 |
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Recruitment Status :
Completed
First Posted : January 11, 2007
Last Update Posted : August 19, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypotension Ischemia | Drug: Hemospan (MP4OX) Drug: Voluven (HES 130/0.4) | Phase 3 |
Hemospan is a novel hemoglobin-based oxygen carrier developed to perfuse and oxygenate tissue at risk for ischemia and hypoxia. As a result of its molecular size and oxygen binding characteristics, Hemospan selectively off-loads oxygen in tissues predisposed to low oxygen tension. Preclinical evidence suggests that Hemospan provides rapid and effective plasma expansion and tissue perfusion, and that the properties of Hemospan target oxygen release in the microcirculation.
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 462 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of an Oxygen-Carrying Plasma Expander, Hemospan®, Compared With Voluven® toTreat Hypotension in Patients Undergoing Primary Hip Arthroplasty With Spinal Anesthesia |
| Study Start Date : | February 2007 |
| Actual Primary Completion Date : | March 2008 |
| Actual Study Completion Date : | April 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Hemospan (MP4OX)
4.3 g/dL MalPEG-Hb solution
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Drug: Hemospan (MP4OX)
250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers
Other Names:
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Active Comparator: Control
Voluven (HES 130/0.4)
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Drug: Voluven (HES 130/0.4)
250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers
Other Names:
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- Total duration of all hypotensive episodes occurring during anesthesia/surgery and throughout the postoperative period (defined as the first 6 hours following skin closure) [ Time Frame: Up to 6 hours after skin closure ]
- Incidence of serious operative and postoperative complications, combined into a Composite Morbidity Outcome that includes acute heart failure, acute MI, ischemic stroke, and renal failure [ Time Frame: 30 days ]
- Incidence of operative and postoperative organ dysfunction related to ischemia and/or tissue hypoxia, as a Composite Ischemia Outcome that includes clinical evidence of cerebral ischemia, myocardial ischemia, and renal dysfunction [ Time Frame: 30 days ]
- Mortality (In-hospital, and all-cause at 30 days) [ Time Frame: 30 days ]
- Time to resolve/correct the initial hypotensive episode that led to the first dosing trigger [ Time Frame: Intraoperative ]
- Time to the second dosing trigger from the first dosing trigger [ Time Frame: Intraoperative ]
- Proportion of patients treated successfully with one dose [ Time Frame: Intraoperative ]
- Incidence of hypotension [ Time Frame: Up to 6 hours after skin closure ]
- Duration of the longest period of hypotension recorded [ Time Frame: Up to 6 hours after skin closure ]
- Incidence of intervention with a pressor agent to treat hypotensive episodes [ Time Frame: Up to 6 hours after skin closure ]
- Incidence of postoperative intervention with a diuretic for volume-overload or inadequate urine output [ Time Frame: Post-operative day 3 ]
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients scheduled to undergo elective primary hip arthroplasty (based on an osteoarthritis diagnosis) under spinal anesthesia
- 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:
- Hip fracture patients and nail/pin extraction procedures
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420277
Show 22 study locations
| Principal Investigator: | Philippe van der Linden, MD, PhD | CHU Brugmann, Brussels |
Other Publications:
| Responsible Party: | Sangart |
| ClinicalTrials.gov Identifier: | NCT00420277 |
| Other Study ID Numbers: |
6090 |
| First Posted: | January 11, 2007 Key Record Dates |
| Last Update Posted: | August 19, 2013 |
| Last Verified: | August 2013 |
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Hip arthroplasty Anesthesia, spinal Hypotension |
Ischemia Blood substitutes Plasma expanders |
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Hypotension Ischemia Pathologic Processes Vascular Diseases Cardiovascular Diseases |
Hydroxyethyl Starch Derivatives Pharmaceutical Solutions Plasma Substitutes Blood Substitutes |