Efficacy and safety of prophylactic large dose of tranexamic acid in spine surgery: a prospective, randomized, double-blind, placebo-controlled study.

STUDY
DESIGN: This is a double blind randomized placebo controlled study, after obtaining approval of ethics committee in the hospital and informed written consent, 64 patients were randomized equally into 2 groups (tranexamic acid (TA) and placebo).
OBJECTIVE: To evaluate efficacy and safety of large doses of TA on blood loss during spinal operations. SUMMARY OF BACKGROUND DATA: Blood loss associated with spinal operations is a common potential cause of morbidity and often requires blood transfusion which subject patients to the known risks of blood transfusion including transmission of diseases. TA is used routinely to reduce bleeding in cardiac, orthopaedic, and hepatic surgery, however, its use in neurosurgery is uncommon and only few studies reported the use of antifibrinolytic drugs in spine surgery.
METHODS: Sixty-four consecutive patients undergoing spinal surgery with expected significant blood loss at King Khalid University Hospital between June 2005 and December 2006 were randomly assigned to 2 groups, TA and placebo. Shortly after the induction of anesthesia, patients received either TA or placebo as a loading dose of 2 g (for adults) or 30 mg/kg (for children), followed immediately by continuous infusion of 100 mg/h (for adults) or 1 mg/kg/h (for children) during surgery and for 5 hours after the operation. Outcome measures included total (i.e., intraoperative and postoperative) blood loss, amount of blood transfusion, as well as postoperative hemoglobin, and hematocrite levels. The data were analyzed by means of Statistical Package for the Social Science Version 12.0. The results were presented as mean +/- SD. Independent Student t test was used to compare the 2 groups and differences were considered significant if the P-value was <0.05.
RESULTS: There were 39 males and 25 females, ranging in age from 4 to 86 years with a mean of 51 and median of 56 years. Eighteen patients had multilevel anterior cervical discectomies with or without internal fixation, 22 patients had decompressive surgery (12 laminectomies and 10 intersegmental decompressions) for multiseg- ment spinal stenosis, 15 patients had laminectomy with posterior spinal fixation, and remaining 9 patients had laminectomy and excision of spinal tumor. Statistical analysis showed no significant differences between the 2 study groups with regard to age, sex, weight, preoperative hemoglobin, and hematocrite levels, type of surgery, as well as operative time. In contrast, patients who received TA had 49% reduction of blood loss (P < 0.007) and required 80% less blood transfusion (P < 0.008) than patients who received placebo. The hospital stay was shorter in the TA group, but it did not achieve statistical significance. There were no complications related to the use of large doses of TA in this study.
CONCLUSIONS: Prophylactic use of large doses of TA provides an effective, safe, and cheap method for reducing blood loss during and after spinal operations. Hence, TAmay help in reducing not only transfusion related complications but also operative expenses. Considering the limited number of patients in this study, our results need, however, to be validated on a larger number of patients, probably in a multicenter study.

RCT Entities:   Population Interventions Outcomes