drugset / Trial / NCT00494949
Increasing Dose Safety Study of Hemospan in Orthopedic Surgery Patients
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to evaluate the safety and possible effectiveness of Hemospan solution in patients undergoing elective orthopedic surgery who receive spinal anesthesia.
Timeline
- Start
- 2003-04
- Primary completion
- 2006-07
- Completion
- 2006-08
Publications
- Background 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.
- Background Winslow RM. Red cell substitutes. Semin Hematol. 2007 Jan;44(1):51-9. doi: 10.1053/j.seminhematol.2006.09.013.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hemospan | Protein / enzyme biologic | 200 ml | — |
| Subject | Hemospan | Protein / enzyme biologic | 400 ml | — |
| Subject | Hemospan | Protein / enzyme biologic | 600 ml | — |
| Subject | Hemospan | Protein / enzyme biologic | 750 ml | — |
| Subject | Hemospan | Protein / enzyme biologic | 1000 ml | — |
| Comparator | Ringer's Lactate | Other / unclassified | 200 ml | — |
| Comparator | Ringer's Lactate | Other / unclassified | 400 ml | — |
| Comparator | Ringer's Lactate | Other / unclassified | 600 ml | — |
| Comparator | Ringer's Lactate | Other / unclassified | 750 ml | — |
| Comparator | Ringer's Lactate | Other / unclassified | 1000 ml | — |