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Background and goal of the study: Hemolink™ is a red cell substitute made from outdated human red cells by lysis, pasteurization, chromatographic purification and cross-linking with o-raffinose. A 10% solution in Ringer's lactate results. This study evaluates the safety/efficacy of Hemolink™ in patients having major orthopaedic surgery. The study was single blind, randomized (2:1) and dose escalation.
Materials and methods: 40 patients at 3 centres received either Hemolink™ (28 patients) or concentrated red blood cells (RBCs) 12 patients. Transfusion occurred if Hb reached 9 g dL−1 within 8 h of surgery at the 250/500 mL doses and within 48 h of surgery, in the 750/1000 mL doses. Patient hemodynamics, clinical chemistry, hematology and physical exam were carried out preoperatively and at 1, 2, 24, 48 and 72 h postsurgery and at days 10 and 6 weeks.
Results and discussion: Six patients received 250 mL, 10 received 500 mL, 6 six received 750 mL and 6 received 1000 mL of Hemolink™ on reaching the 9 g dL−1 trigger. Thereafter, red cells were transfused as routine. Hemolink™ treatment increased serum haemoglobin levels from 0.13 to 3.4 g dL−1 with increasing doses. 10 (36%) patients had elevated blood pressure related to Hemolink™ use. One patient with undetected coronary artery disease suffered a myocardial infarction after receiving Hemolink™ and RBCs. 10 (36%) Hemolink™ patients had elevated bilirubin consistent with the metabolism of the Hemolink™. No clinically significant liver enzyme changes were noted. Amylase was elevated in 6 (21%) of Hemolink™ patients and 1 (8%) RBC patient. GI symptoms were more common in the Hemolink™ patients (nausea 18 (64%) vs. 5 (42%), vomiting 15 (54%) vs. 4 (33%). 2 (16%) patients had dysphagia. Hemolink™ did not cause renal dysfunction. In patients receiving Hemolink™, transfusion of RBCs was delayed for about 30 h (range 4-68 h) after the first transfusion trigger was met.
Conclusion: Hemolink™ can postpone blood transfusion in orthopaedic patients. Hypertension and GI symptoms may limit its use in an elderly frail population, in this study design.
Acknowledgements: This study was funded by Hemosol Inc., Etobicoke, Canada.
