Key result
Tranexamic acid significantly decreased mean intra-operative blood loss compared to normal saline (1042.65 ml vs 1149.25 ml, p=0.033) in patients undergoing spine stabilization surgeries.
Why the study?
Does tranexamic acid reduce intra-operative blood loss and transfusion requirements in patients undergoing spine stabilization surgeries?
RCT (n=40)
Double-blind
Computer generated random number table
No
Does tranexamic acid reduce intra-operative blood loss and transfusion requirements in patients undergoing spine stabilization surgeries?
Absolute Event Rate: 1042.65% vs 1149.25%
p-value: p=0.033
Prophylactic tranexamic acid significantly reduces intra-operative blood loss during spine stabilization surgeries without increasing thromboembolic complications.
Supports tranexamic acid prophylaxis in spine stabilization; confirms efficacy in this RCT population.
BACKGROUND: Spine surgeries may involve uncontrolled bleeding, resulting primarily from large vein and persists even after the wound is closed. Proper patient positioning, use of hypotensive anaesthesia regimen and normothermia reduces blood loss, additional measures to reduce bleeding & transfusion requirement must be considered in spine surgery. MATERIALS AND METHODS: Forty patients of both sexes between the age group 21 to 60 years belonging to ASA I to III who were scheduled for spine stabilization surgeries was enrolled for the study were randomized into two groups with 20 in each. Anaesthetic technique was standardized. Group T received Tranexamic acid bolus of 10 mg/kg i.v. over 15 min. after patient positioning followed maintenance infusion of 1mg/kg/hr. And Group N Equivalent volume of Normal saline. Intra-operative blood losses was measured by weighing sponges, measuring suction drainage and estimates of blood loss on the surgical drapes and gowns by the attending anesthesiologist. Post-operative blood losses were assessed by measuring wound drainage until drains withdrawal. Investigations like Hb, Platelet, PT and APTT were done pre and post-operatively. Patients were assessed postoperatively daily for any clinical evidence of deep venous thrombosis. RESULTS: Pre-operative haemoglobin in group T and N were 13.561.171 and 12.981.488 gm% respectively. Post-operative haemoglobin in group T and N were 11.971.351 and 11.071.044 gm% respectively. There was a statistically significant drop in haemoglobin in control group post operatively. (p=0.024)Mean intra-operative blood loss in group T was 1042.65 147.535 ml and in group N 1149.25 157.85 ml. Control group had higher intraoperative blood loss compared to Tranexamic acid group, which was statistically significant. (p=0.033).There was no difference in mean drop in haemoglobin, mean number of units of blood transfusion among study groups. CONCLUSION: Tranexamic acid in bolusdosage of 10 mg/kg i.v. over 15 min. after patient positioning followed maintenance infusion of 1mg/kg/hr significantly decreases intra-operative blood loss, thereby decreasing the requirement of intraoperative blood transfusion. However it does not have any major impact on post-operative blood loss. No thrombotic complications or other adverse events were noted in this study.
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Pradeep et al. (2014) conducted an RCT in Spine stabilization surgeries (n=40). Tranexamic acid vs. Normal saline was evaluated on Intra-operative blood loss (ml) (p=0.033). Tranexamic acid significantly decreased mean intra-operative blood loss compared to normal saline (1042.65 ml vs 1149.25 ml, p=0.033) in patients undergoing spine stabilization surgeries.
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