A randomized, single-blind, increasing dose safety trial of an oxygen-carrying plasma expander (Hemospan®) administered to orthopaedic surgery patients with spinal anaesthesia

Transfusion Medicine

Volumn 18, Issue 1, 2008, Pages 28-39

  Olofsson, C ^a   Nygards E B ^a   Ponzer, S ^b   Fagrell, B ^a   Przybelski, R ^c   Keipert, P E ^d   Winslow, N ^d   Winslow, R M ^d,e,f  

^a KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^b KAROLINSKA INSTITUTE   (Sweden)

^c UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^f SANGART INC   (United States)

Author keywords

Blood substitutes; Clinical trials; Haemoglobin; Haemoglobin based oxygen carriers; MP4; Oxygen therapeutics; PEG; Spinal anaesthesia

Indexed keywords

ALANINE AMINOTRANSFERASE; ALFENTANIL; ALKALINE PHOSPHATASE; AMYLASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; BUPIVACAINE; CELECOXIB; CREATINE KINASE; CREATINE KINASE MB; DALTEPARIN; DIXYRAZINE; ENOXAPARIN; FENTANYL; GAMMA GLUTAMYLTRANSFERASE; HEMOGLOBIN; HEMOSPAN; INFUSION FLUID; IOHEXOL; METHEMOGLOBIN; METHOTREXATE; MIDAZOLAM; NARCOTIC ANALGESIC AGENT; NONSTEROID ANTIINFLAMMATORY AGENT; PLASMA SUBSTITUTE; PROPOFOL; RINGER LACTATE SOLUTION; SEVOFLURANE; SUFENTANIL CITRATE; TRIACYLGLYCEROL LIPASE; TROPONIN T; UNCLASSIFIED DRUG;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; AMYLASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BLOOD GAS ANALYSIS; BRADYCARDIA; CLINICAL ARTICLE; CLINICAL TRIAL; COLLOID; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; CRYSTALLOID; DEMOGRAPHY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG HALF LIFE; DRUG SAFETY; ECG ABNORMALITY; ELECTROCARDIOGRAPHY; FEMALE; FLUID BALANCE; FLUID THERAPY; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GASTROINTESTINAL SYMPTOM; HUMAN; HYPOTENSION; INFECTION; MALE; MEAN ARTERIAL PRESSURE; MUSCULOSKELETAL DISEASE; NAUSEA; NEUROLOGIC DISEASE; ORTHOPEDIC SURGERY; OXYGEN AFFINITY; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; SIDE EFFECT; SINGLE BLIND PROCEDURE; SPINAL ANESTHESIA; STATISTICAL ANALYSIS; TRANSFUSION; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; URINE VOLUME; VITAL SIGN; VOLUNTEER;

ADULT; AGED; ANESTHESIA, SPINAL; BLOOD PRESSURE; COHORT STUDIES; CONTRAST MEDIA; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; IOHEXOL; ISOTONIC SOLUTIONS; MALE; MIDDLE AGED; ORTHOPEDIC PROCEDURES; PLASMA SUBSTITUTES; SINGLE-BLIND METHOD; TIME FACTORS;

EID: 39049134910     PISSN: 09587578     EISSN: 13653148     Source Type: Journal    
DOI: 10.1111/j.1365-3148.2007.00811.x     Document Type: Article

References (20)

1. Björkholm, M., Fagrell, B., Przybelski, R., Winslow, N., Young, M. Winslow, R 2005) A phase I single blind clinical trial of a new oxygen transport agent (MP4), human hemoglobin modified with maleimide-activated polyethylene glycol. Haematologica, 90, 505 515.
2. Cheng, D.C.H., Mazer, C.D., Martineau, R. et al 2004) A phase II dose-response study of hemoglobin raffimer (Hemolink) in elective coronary artery bypass surgery. Journal of Thoracic and Cardiovascular Surgery, 127, 70 86.
3. Cole, R.H., Vandegriff, K.D., Szeri, A.J., Savas, Ö., Baker, D.A. Winslow, R.M (2007) A quantitative framework for the design of acellular hemoglobins as blood substitutes: implications of dynamic flow conditions. Biophysical Chemistry, 128, 63 74.
4. Drobin, D., Kjellström, B., Malm, E., Malavalli, A., Lohman, J., Vandegriff, K., Young, M. Winslow, R 2004) Hemodynamic response and oxygen transport in pigs resuscitated with maleimide-polyethylene glycol-modified hemoglobin (MP4). Journal of Applied Physiology, 96, 1843 1853.
5. Evelyn, K. Malloy, H 1938) Microdetermination of oxyhemoglobin, methemoglobin and sulfhemoglobin in a single sample of blood. Journal of Biological Chemistry, 126, 655 662.
6. Garrioch, M.A., McClure, J.H. Wildsmith, A.W 1999) Haemodynamic effects of diaspirin crosslinked haemoglobin (DCLHb) given before abdominal aortic aneurysm surgery. British Journal of Anaesthesia, 83, 702 707.
7. Hill, S.E., Gottschalk, L.I. Grichnik, K 2002) Safety and preliminary efficacy of hemoglobin raffimer for patients undergoing coronary artery bypass surgery. Journal of Cardiothoracic and Vascular Anesthesia, 16, 695 702.
8. McCarthy, M.R., Vandegriff, K.D. Winslow, R.M 2001) The role of facilitated diffusion in oxygen transport by cell-free hemoglobins: implications for the design of hemoglobin-based oxygen carriers. Biophysical Chemistry, 92, 103 117.
9. Olofsson, C., Nygårds, E.B., Bjersten, A.B. Hessling, A 2004) Low-dose bupivacaine with sufentanil prevents hypotension after spinal anesthesia for hip repair in elderly patients. Acta Anaesthesiologica Scandinavica, 48, 1240 1244.
10. Olofsson, C., Ahl, T., Johansson, T. et al 2006) A multi-center clinical study of the safety and activity of maleimide-polyethylene glycol hemoglobin (Hemospan®) in patients undergoing major orthopedic surgery. Anesthesiology, 105, 1153 1163.
11. Roger, V.L., Killian, J.M., Weston, S.A. et al 2006) Redefinition of myocardial infarction: prospective evaluation in the community. Circulation, 114, 790 797.
12. Toy, P., Kaplan, E., McVay, P.A., Lee, S., Strauss, R. Stehling, L 1992) Blood loss and replacement in total hip arthroplasty: a multicenter study. Transfusion, 32, 63 67.
13. 2 therapeutics. American Journal of Physiology, 285, H1411 H1419.
14. Tsai, A.G., Cabrales, P., Acharya, S., Manjula, B.N., Winslow, R.M. Intaglietta, M 2006) Dissociation of local nitric oxide concentration and vasoconstriction in the presence of cell-free hemoglobin oxygen carriers. Blood, 108, 3603 3610.
15. Vandegriff, K.D., Malavalli, A., Wooldridge, J., Lohman, J. Winslow, R.M 2003) MP4, a new nonvasoactive PEG-Hb conjugate. Transfusion, 43, 509 516.
16. 2 binding to MP4, a polyethylene glycol conjugated hemoglobin. Journal of Biological Chemistry, 382, 183 189.
17. Winslow, R 2007) Red cell substitutes. Seminars in Hematology, 44, 51 59.
18. Winslow, R.M., Swenberg, M., Berger, R., Shrager, R., Luzzana, M. Samaja, M 1977) Oxygen equilibrium curve of normal human blood and its evaluation by Adair's equation. Journal of Biological Chemistry, 252, 2331 2337.
19. Winslow, R., Swenberg, M., Benson, J., Perrella, M. Benazzi, L 1989) Gas-exchange properties of goat hemoglobin A and C. Journal of Biological Chemistry, 264, 4812 4817.
20. Young, M., Riddez, L., Kjellström, T., Bursell, J., Winslow, F., Lohman, J. Winslow, R 2005) MalPEG-hemoglobin (MP4) improves hemodynamics, acid-base status, and survival after uncontrolled hemorrhage in anesthetized swine. Critical Care Medicine, 33, 1794 1804.