Blood Loss Clinical Trial
Official title:
A Post-Market, Prospective, Multicenter, Randomized Trial Comparing the Use of Standard of Care Blood Sparing Techniques With and Without the Aquamantys System to Facilitate Hemostasis in Subjects Undergoing Multi-level Spinal Fusions
The purpose of this study is to compare standard of care hemostasis techniques with and without the use of Aquamantys in reducing peri-operative blood loss.
The primary objective of the study is to assess the effectiveness of Aquamantys in reducing
peri-operative blood loss compared with standard electrocautery
Secondary objectives include :
- Rate and volume of transfusions
- Evaluating the reduction in hemoglobin and hematocrit values post- operatively
- LOS costs, and operative time
- Gathering operator feedback on qualitative criteria, including ease of use and surgical
visualization between the two treatment groups
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