STUDY DESIGN: A double-blind, randomized, prospective clinical study was performed to evaluate the efficacy of deamino-8-D-arginin vasopressin in reducing blood loss in major scoliosis surgery. OBJECTIVES: To evaluate whether desmopressin has any effect on reducing blood loss in spinal surgery, to identify the probable mechanisms of effectiveness via blood coagulation factors, and to outline any adverse effect associated with the use of deamino-8-D-arginin vasopressin. SUMMARY OF BACKGROUND DATA: Scoliosis surgery is known to be associated with major blood loss. Because of major drawbacks of homologous blood transfusion, many alternative methods have been used to counter the blood loss. Only a few studies exist, with controversial results, on the use of deamino-8-D-arginin vasopressin. METHODS: The study population included 40 operations on 35 consecutive patients undergoing reconstructive surgery for either idiopathic (n = 26) or congenital (n = 9) scoliosis. Operations were randomized into deamino-8-D-arginin vasopressin (0.3 microgram/kg body weight; maximum, 20 micrograms) (n = 18) or placebo (n = 22) groups and stratified according to the diagnosis and the type of surgery performed (i.e., anterior versus posterior versus anterior and posterior sequential). Parameters of blood loss, serum levels of blood coagulation factors at different time intervals, and urinary output were measured. RESULTS: Findings indicated that blood loss per kilogram of body weight, blood loss per surgically treated spinal level, urinary output per kilogram of body weight and serum levels of fibrinogen, von Willebrand factor (vWF) activity, tissue type plasminogen activator activity, and plasminogen activator inhibitor activity were not sensitive to the administration of deamino-8-D-arginin vasopressin at any time interval during surgery or at 24 hours after surgery (P > 0.05). Only factor VIII:C levels exhibited significant elevations at 30 minutes and at 24 hours (P < 0.05). CONCLUSIONS: This study could not demonstrate any significant effect of deamino-8-D-arginin vasopressin on the amount of blood loss in a group of patients with idiopathic or congenital scoliosis. Findings indicate that for most of the coagulation factors, any changes in serum levels induced by deamino-8-D-arginin vasopressin were much like those expected from surgery itself. This study also failed to demonstrate any significant effects altering the urinary output that may be attributed to the use of deamino-8-D-arginin vasopressin.
RCT Entities:
STUDY DESIGN: A double-blind, randomized, prospective clinical study was performed to evaluate the efficacy of deamino-8-D-argininvasopressin in reducing blood loss in major scoliosis surgery. OBJECTIVES: To evaluate whether desmopressin has any effect on reducing blood loss in spinal surgery, to identify the probable mechanisms of effectiveness via blood coagulation factors, and to outline any adverse effect associated with the use of deamino-8-D-argininvasopressin. SUMMARY OF BACKGROUND DATA: Scoliosis surgery is known to be associated with major blood loss. Because of major drawbacks of homologous blood transfusion, many alternative methods have been used to counter the blood loss. Only a few studies exist, with controversial results, on the use of deamino-8-D-argininvasopressin. METHODS: The study population included 40 operations on 35 consecutive patients undergoing reconstructive surgery for either idiopathic (n = 26) or congenital (n = 9) scoliosis. Operations were randomized into deamino-8-D-argininvasopressin (0.3 microgram/kg body weight; maximum, 20 micrograms) (n = 18) or placebo (n = 22) groups and stratified according to the diagnosis and the type of surgery performed (i.e., anterior versus posterior versus anterior and posterior sequential). Parameters of blood loss, serum levels of blood coagulation factors at different time intervals, and urinary output were measured. RESULTS: Findings indicated that blood loss per kilogram of body weight, blood loss per surgically treated spinal level, urinary output per kilogram of body weight and serum levels of fibrinogen, von Willebrand factor (vWF) activity, tissue type plasminogen activator activity, and plasminogen activator inhibitor activity were not sensitive to the administration of deamino-8-D-argininvasopressin at any time interval during surgery or at 24 hours after surgery (P > 0.05). Only factor VIII:C levels exhibited significant elevations at 30 minutes and at 24 hours (P < 0.05). CONCLUSIONS: This study could not demonstrate any significant effect of deamino-8-D-argininvasopressin on the amount of blood loss in a group of patients with idiopathic or congenital scoliosis. Findings indicate that for most of the coagulation factors, any changes in serum levels induced by deamino-8-D-argininvasopressin were much like those expected from surgery itself. This study also failed to demonstrate any significant effects altering the urinary output that may be attributed to the use of deamino-8-D-argininvasopressin.
Authors: Balkan Cakir; Benjamin Ulmar; René Schmidt; Georg Kelsch; Peter Geiger; Hans-Hinrich Mehrkens; Wolfhart Puhl; Marcus Richter Journal: Eur Spine J Date: 2005-02-15 Impact factor: 3.134