Double-blind, randomized controlled trial of tranexamic acid in minor lumbar spine surgery: no effect on operative time, intraoperative blood loss, or complications

2019 ◽  
Vol 31 (2) ◽  
pp. 194-200 ◽  
Author(s):  
Signe Elmose ◽  
Mikkel Ø. Andersen ◽  
Else Bay Andresen ◽  
Leah Yacat Carreon

OBJECTIVEThe purpose of this study was to investigate the effect of tranexamic acid (TXA) compared to placebo in low-risk adult patients undergoing elective minor lumbar spine surgery—specifically with respect to operative time, estimated blood loss, and complications. Studies have shown that TXA reduces blood loss during major spine surgery. There have been no previous studies on the effect of TXA in minor lumbar spine surgery in which these variables have been evaluated.METHODSThe authors enrolled patients with ASA grades 1 to 2 scheduled to undergo lumbar decompressive surgery at Middelfart Hospital into a double-blind, randomized, placebo-controlled, parallel-group study. Patients with thromboembolic disease, coagulopathy, hypersensitivity to TXA, or a history of convulsion were excluded. Patients were randomly assigned, in blocks of 10, to one of 2 groups, TXA or placebo. Anticoagulation therapy was discontinued 2–7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10 mg/kg) or an equivalent volume of saline solution (placebo). Independent t-tests were used to compare differences between the 2 groups, with statistical significance set at p < 0.05.RESULTSOf the 250 patients enrolled, 17 patients were excluded, leaving 233 cases for analysis (117 in the TXA group and 116 in the placebo group). The demographics of the 2 groups were similar, except for a higher proportion of women in the TXA group (TXA 50% vs placebo 32%, p = 0.017). There was no significant between-groups difference in operative time (49.53 ± 18.26 vs 54.74 ± 24.49 minutes for TXA and placebo, respectively; p = 0.108) or intraoperative blood loss (55.87 ± 48.48 vs 69.14 ± 83.47 ml for TXA and placebo, respectively; p = 0.702). Postoperative blood loss measured from drain output was 62% significantly lower in the TXA group (13.03 ± 21.82 ml) than in the placebo group (34.61 ± 44.38 ml) (p < 0.001). There was no significant difference in number of dural lesions or postoperative spinal epidural hematomas, and there were no thromboembolic events.CONCLUSIONSTranexamic acid did not have a statistically significant effect on operative time, intraoperative blood loss, or complications. This study gives no evidence to support the routine use of TXA during minor lumbar decompressive surgery.Clinical trial registration no.: NCT03714360 (clinicaltrials.gov)

2020 ◽  
Vol 33 (2) ◽  
pp. 177-185 ◽  
Author(s):  
Jeff Ehresman ◽  
Zach Pennington ◽  
Andrew Schilling ◽  
Ravi Medikonda ◽  
Sakibul Huq ◽  
...  

OBJECTIVEBlood transfusions are given to approximately one-fifth of patients undergoing elective lumbar spine surgery, and previous studies have shown that transfusions are accompanied by increased complications and additional costs. One method for decreasing transfusions is administration of tranexamic acid (TXA). The authors sought to evaluate whether the cost of TXA is offset by the decrease in blood utilization in lumbar spine surgery patients.METHODSThe authors retrospectively reviewed patients who underwent elective lumbar or thoracolumbar surgery for degenerative conditions at a tertiary care center between 2016 and 2018. Patients who received intraoperative TXA (TXA patients) were matched with patients who did not receive TXA (non-TXA patients) by age, sex, BMI, ASA (American Society of Anesthesiologists) physical status class, and surgical invasiveness score. Primary endpoints were intraoperative blood loss, number of packed red blood cell (PRBC) units transfused, and total hemostasis costs, defined as the sum of TXA costs and blood transfusion costs throughout the hospital stay. A subanalysis was then performed by substratifying both cohorts into short-length (1–4 levels) and long-length (5–8 levels) spinal constructs.RESULTSOf the 1353 patients who met inclusion criteria, 68 TXA patients were matched to 68 non-TXA patients. Patients in the TXA group had significantly decreased mean intraoperative blood loss (1039 vs 1437 mL, p = 0.01). There were no differences between the patient groups in the total costs of blood transfusion and TXA (p = 0.5). When the 2 patient groups were substratified by length of construct, the long-length construct group showed a significant net cost savings of $328.69 per patient in the TXA group (p = 0.027). This result was attributable to the finding that patients undergoing long-length construct surgeries who were given TXA received a lower amount of PRBC units throughout their hospital stay (2.4 vs 4.0, p = 0.007).CONCLUSIONSTXA use was associated with decreased intraoperative blood loss and significant reductions in total hemostasis costs for patients undergoing surgery on more than 4 levels. Furthermore, the use of TXA in patients who received short constructs led to no additional net costs. With the increasing emphasis put on value-based care interventions, use of TXA may represent one mechanism for decreasing total care costs, particularly in the cases of larger spine constructs.


Neurosurgery ◽  
2017 ◽  
Vol 64 (CN_suppl_1) ◽  
pp. 245-246
Author(s):  
John Thomas Pierce ◽  
Prateek Agarwal ◽  
Paul J Marcotte ◽  
William Charles Welch

Abstract INTRODUCTION Lumbar spine surgery can be successfully performed using various anesthetic techniques. Previous studies have shown varying results in selected outcomes when directly comparing spinal anesthesia (SA) to general anesthesia (GA) in lumbar surgery. We sought to elucidate the more expedient anesthetic technique. METHODS Following IRB approval, a retrospective review of patients undergoing elective lumbar decompression surgery using GA or SA was performed. Demographic data known to influence perioperative morbidity was collected as well as safety and efficiency parameters. After controlling for patient and procedure characteristics, simple linear and multivariate regression analyses were performed to identify differences in operative blood loss, operative time, time from entering the OR until incision, time from bandage placement to exiting the OR, total anesthesia time, time in the post-anesthesia care unit (PACU), and length of hospital stay. RESULTS >544 consecutive lumbar laminectomy and discectomy surgeries were identified with 183 undergoing GA and 361 undergoing SA. The following times were all shorter for patients receiving SA than GA: operative time (97.4 vs. 151.8 min., P < 0.001), total anesthesia time (145.6 vs. 217.5 min., P < 0.001), time from entering the OR until incision (38.3 vs. 46.8 min., respectively, P < 0.001), time from bandage placement until exiting the OR (10.2 vs. 17.2 min., P < 0.001), and length of hospital stay (1.5 vs. 3.1 days, P < 0.001). The mean PACU length of stay was longer in the SA group than the GA group (178.0 vs. 116.5 min., P < 0.001). Estimated blood loss was less in the SA group than the GA group (62.1 vs. 176.3 mL, P < 0.001). CONCLUSION Spinal anesthesia may be the more expedient method of anesthesia in lumbar spinal surgery for all perioperative time points except for time in the PACU.


2021 ◽  
Vol 12 ◽  
pp. 272
Author(s):  
Gopala K. Ravi ◽  
Nidhi Panda ◽  
Jasmina Ahluwalia ◽  
Rajeev Chauhan ◽  
Navneet Singla ◽  
...  

Background: Resection of intracranial meningioma has been associated with significant blood loss. Providing a clear surgical field and maintaining hemodynamic stability are the major goals of anesthesia during meningioma surgery. Tranexamic acid has been used to reduce blood loss in various neurosurgical settings with limited evidence in literature. A randomized, double-blind, and placebo-controlled trial was conducted to evaluate the efficacy of tranexamic acid on blood loss, coagulation profile, and quality of surgical field during resection of intracranial meningioma. Methods: Thirty patients aged 18–65 years undergoing elective meningioma resection surgery were given either tranexamic acid or placebo (0.9% saline), tranexamic acid at a loading dose of 20 mg/kg, and infusion of 1 mg/kg/h during surgery. The intraoperative blood loss, coagulation profile, and the surgical field using Likert scale were assessed. Results: The patients in tranexamic group had significantly decreased intraoperative blood loss compared to the placebo group (616.42 ± 393.42 ml vs. 1150.02 ± 416.1 ml) (P = 0.02). The quality of the surgical field was better in the tranexamic group (median score 4 vs. 2 on Likert Scale) (P < 0.001). Patients in tranexamic group had an improved coagulation profile and decreased blood transfusion requirement (p=0.016). The blood collected in closed suction drain in 24 h postsurgery was less in the tranexamic acid group compared to placebo group (84.7 ± 50.4 ml vs. 127.6 ± 62.2 ml) (P = 0.047). Conclusion: Tranexamic acid bolus followed by infusion reduces perioperative blood loss by 46.43% and blood transfusion requirement with improved surgical field and coagulation profile in patients undergoing intracranial meningioma resection surgery.


2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Tamer Hamed Ibrahim

Abstract Background Placenta accreta is an obstetric emergency and the main cause of maternal morbidity and mortality due to the associated bleeding and coagulopathy. Tranexamic acid has been widely used to decrease blood loss in trauma patients and patients with postpartum hemorrhage. We aimed at studying the effect of tranexamic acid in reducing blood loss and blood transfusion in patients with placenta accreta. Methods In a double-blinded randomized controlled study, 46 patients were recruited and divided into two groups, Group A is the tranexamic group where patients received 10 mg/kg tranexamic acid after cord clamping and continued on tranexamic infusion 10 mg/kg/h till the end of the surgery. Group B is the placebo where patients received normal saline instead. Primary outcome was the amount of intraoperative blood loss, and other outcomes included the number of blood and blood products transfused intraoperative and in the first 24 h postoperative, the immediate postoperative Hb level, platelet count, and coagulation profile. Data were collected, coded, tabulated, and then analyzed using Minitab® 16.1.0 statistics software package. Variables were presented as mean and standard deviation and analyzed using unpaired t test. Any difference with p value < 0.05 was considered statistically significant. Results Amount of intraoperative blood loss was significantly less in the tranexamic group 2232 ± 1204 ml compared to the placebo group 3405 ± 1193 ml (p value 0.002), and patients in the tranexamic group received less units of packed red blood cells, fresh frozen plasma, and platelets compared to those in the placebo group (4.2 ± 1.9 vs 6.1 ± 2.2 with p value 0.003, 3.4 ± 1.3 vs 4.2 ± 1.2 with P value 0.036 and 4.8 ± 2.1 vs 6.2 ± 2.4 with p value 0.041, respectively). There was no statistically significant difference in the first postoperative Hb level, platelet count, and coagulation profile between the two groups; however, the amount of blood and products transfused in the first 24 h postoperative were significantly less in the tranexamic group Conclusion Tranexamic acid infusion was effective in reducing intraoperative blood loss and intraoperative and postoperative blood and blood products’ transfusion.


Vascular ◽  
2013 ◽  
Vol 22 (4) ◽  
pp. 246-251 ◽  
Author(s):  
Anahita Dua ◽  
Jennifer Fox ◽  
Bhavin Patel ◽  
Eric Martin ◽  
Michael Rosner ◽  
...  

We report a five year military experience with anterior retroperitoneal spine exposure combining vascular and neurosurgical spine teams. From August 2005 through April 2010 (56 months), hospital records from a single institution were retrospectively reviewed. Complications, estimated blood loss, transfusions, operative time and length of stay were documented. Eighty-four patients with lumbar spondylosis underwent primary (63, 75%) or secondary exposure (21, 25%) of a single- (66, 79%) or multilevel disc space (18, 21%). Median operative time and estimated blood loss were 127 minutes (range, 30–331 minutes) and 350 mL (range, 0–2940 mL). The overall complication rate was 23.8%. Postoperative complications included six blood transfusions (7%), three patients with retrograde ejaculation (3.57%) or surgical site infection; two with a prolonged ileus (2.38%) or ventral hernia and one each with a bowel obstruction (1, 1.19%), deep venous thrombosis or lymphocele. All-cause mortality was 1%. In conclusion, a team approach can minimize complications while offering the technical benefits and durability of an anterior approach to the lumbar spine.


2000 ◽  
Vol 17 (Supplement 19) ◽  
pp. 121-122
Author(s):  
E. Facco ◽  
M. Munari ◽  
F. Gallo ◽  
S. M. Volpin ◽  
F. Baratto ◽  
...  

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