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The effect of perioperative sequential application of multiple doses of tranexamic acid on postoperative blood loss after PLIF: A prospective randomized controlled trial
Dong, W., Tang, Y., Lei, M., Ma, Z., Zhang, X., Shen, J., Hao, J., Jiang, W., Hu, Z.
International journal of surgery (London, England). 2024
Abstract
BACKGROUND Tranexamic acid (TXA) has been utilized in spinal surgery to effectively reduce intraoperative blood loss (IBL) and allogeneic blood transfusion rates. However, the traditional TXA regimen might last the entire duration of hyperfibrinolysis caused by surgical trauma, resulting in its limited ability to reduce postoperative blood loss (PBL). Therefore, the aim of this study was to investigate the effectiveness of perioperative sequential administration of multiple doses of TXA in reducing PBL in patients who underwent posterior lumbar interbody fusion (PLIF). METHODS From February 2022 to June 2023, 231 patients who were diagnosed with lumbar degenerative disease and scheduled to undergo PLIF were prospectively enrolled in the present study. The patients were randomly divided into three groups. Moreover, all patients received an intravenous injection of TXA at a dose of 15 mg/kg 15 min before surgical skin incision. Patients in Group A received a placebo of normal saline after surgery, while patients in Group B received three additional intravenous injections of TXA at a dose of 15 mg/kg every 24 h. Patients in Group C received three additional intravenous injections of TXA at a dose of 15 mg/kg every 5 h. The primary outcome measure was PBL. In addition, this study assessed total blood loss (TBL), IBL, routine blood parameters, liver and kidney function, coagulation parameters, fibrinolysis indexes, inflammatory indicators, drainage tube removal time (DRT), length of hospital stay (LOS), blood transfusion rate, and incidence of complications for all subjects. RESULTS The PBL, TBL, DRT, and LOS of Group B and Group C were significantly lower than those of Group A (P<0.05). The level of D-dimer (D-D) in Group C was significantly lower than that in Group A on the first day after the operation (P=0.002), and that in Group B was significantly lower than that in Group A on the third day after the operation (P=0.003). The interleukin-6 levels between the three groups from 1-5 days after the operation were in the order of Group A > Group B > Group C. No serious complications were observed in any patient. The results of multiple stepwise linear regression analysis revealed that PBL was positively correlated with incision length, IBL, smoking history, history of hypertension, preoperative fibrinogen degradation product (FDP) level, and blood transfusion. It was negatively correlated with preoperative levels of fibrinogen (FIB), red blood cells (RBCs), blood urea nitrogen (BUN), and age. Compared to female patients, male patients had an increased risk of PBL. Finally, the incidence of PBL was predicted. CONCLUSIONS Sequential application of multiple doses of TXA during the perioperative period could safely and effectively reduce PBL and TBL, shorten DRT and LOS, reduce postoperative D-D generation, and reduce the postoperative inflammatory response. In addition, this study provided a novel prediction model for PBL in patients undergoing PLIF.
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Effect of postoperative tranexamic acid on recurrence rate and complications in chronic subdural hematomas patients: preliminary results of a randomized controlled clinical trial
de Paula Mvct, Ribeiro BDC, Melo MM, de Freitas PVV, Pahl FH, de Oliveira MF, Rotta JM
Neurosurgical review. 2023;46(1):90
Abstract
Chronic subdural hematoma (CSDH) is a frequent neurosurgical disease which mainly affects elderly patients. Tranexamic acid (TXA) has been hypothesized as an oral agent to avoid CSDH progression and/or recurrence. We performed an evaluation to determine whether the postoperative use of TXA reduces recurrence rate. A prospective, randomized, and controlled trial. Patients with unilateral or bilateral chronic subdural hematoma undergoing surgical treatment by burr-hole were randomized as to whether or not to use TXA in the postoperative period. We evaluated image and clinical recurrence of CSDH at follow up of 6 months and potential clinical and/or surgical complications impact of TXA. Twenty-six patients were randomized to the control group (52%) and twenty-four patients to the TXA group (48%). Follow-up ranged from 3 to 16 months. There were no significant difference between baseline data in groups regarding to age, gender, use of antiplatelet or anticoagulants, smoking, alcoholism, systemic arterial hypertension, diabetes mellitus, hematoma laterality, hematoma thickness, and drain use. Clinical and radiological recurrence occurred in three patients (6%), being two cases in TXA group (8.3%) and 1 in control group (3.8%). Postoperative complications occurred in two patients during follow-up (4%), being both cases in TXA group (8.3%), and none in the control group. Although TXA group had a higher recurrence rate (8.3%), there was no statistically significant difference between the two groups. Moreover, TXA group had two complications while control group had no complications. Although limited by experimental nature of study and small sample, our current data suggest that TXA should not be used as a potential agent to avoid recurrences of CSDH and might increase complication odds.
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The Effect of Tranexamic Acid and Controlled Hypotension on Perioperative Blood Loss in Craniosynostosis Surgery
Moradi Farsani, D., Mazaheri, Z., Shafa, A.
Anesthesiology and pain medicine. 2023;13(1):e130462
Abstract
BACKGROUND Open cranial vault reconstruction is the standard technique of craniosynostosis correction that may cause significant blood loss. OBJECTIVES The current study aimed at comparing the effect of tranexamic acid (TXA), controlled hypotension, and their combination on perioperative blood loss and transfusion requirement in craniosynostosis surgery. METHODS The present randomized, double-blind clinical trial was conducted on 75 infants referred for craniosynostosis surgery during 2017 - 2018. Ten minutes before the start of surgery, 10 mg/kg of TXA was administered intravenously to patients in the first group (TXA group). In the second group, patients were subjected to the controlled hypotension anesthesia (CHA) using intravenous remifentanil 0.1 μ/kg (CHA group). In the third group, the patients underwent CHA similar to that of the second group, along with intravenous injection of 10 mg/kg of TXA (CHA-TXA group). Then, patients' mean arterial pressure (MAP), heart rate (HR), total blood loss, and transfusion volume were evaluated and recorded. RESULTS The results of the present study revealed that although the changes in MAP and HR parameters over time (three hours after surgery) were significant in all three groups, the lowest decrease was observed in the CHA-TXA group (P-value < 0.05). In addition, the total perioperative blood loss in the CHA-TXA group with the mean of 181.20 ± 82.71 cc was significantly less than the total perioperative blood loss in the CHA and TXA groups with the means of 262.00 ± 104.04 cc and 212.80 ± 80.75 cc, respectively (P-value < 0.05). Moreover, the transfusion volume in the CHA-TXA group with the mean of 112.40 ± 53.50 cc was significantly lower than the transfusion volume in the CHA and TXA groups with the means of 174.00 ± 73.93 cc and 160.63 ± 59.35 cc, respectively (P-value < 0.05). In contrast, the total blood loss and transfusion volume were not significantly different between the CHA and TXA groups (P-value > 0.05). CONCLUSIONS According to the results of the present study, although the administration of TXA alone could effectively prevent blood loss and was associated with fewer transfusion requirements, the combination of this approach with hypotensive anesthesia resulted in more reduction in perioperative blood loss and transfusion volume as well as better hemodynamic stability.
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Single dose of tranexamic acid effectively reduces blood loss in patients undergoing spine surgery: a prospective randomized controlled trial
Alejandro RS, Alejandro DS, Barón ZK, Javier GG, Rocío GGp, Huffman C, Luis M Ro, Armando AA, Carla LGr
World neurosurgery. 2023
Abstract
STUDY DESIGN Randomized control trial. OBJECTIVE Evaluate the efficacy of oral administration of tranexamic acid (TXA) in spine surgeries to achieve blood loss reduction. METHODS A total of 60 patients undergoing major surgery of the spine, were randomly assigned into 2 groups. Group 1 was assigned as the control group and the other one included oral administration of tranexamic acid 2 hours prior to surgery. Outcomes measures included intraoperative blood loss, postoperative blood loss, hematological parameters, blood transfusion needed, and surgical complications. RESULTS Sixty patients linked up with the inclusion criteria. Intraoperative blood loss was significantly lower in the TXA oral group than in the control group, total blood loss in the TXA group with 930.66±614ml lower than the control group with 1075.66±956.11ml. The mean reduction of hemoglobin was almost the same in both groups. Similarly, the total transfusion package received was lower, and the number of complications and length of stay were akin in both groups. A logistic regression model was performed with patients who had blood loss of more than 1000ml and, surgery time longer than 230min. This was related to the risk of bleeding with an OR of 1.31, 95%CI 1.004-1.023, p=0.004 independent of the group. CONCLUSION Oral TXA results as an effective measure for reducing total blood loss among patients undergoing elective spine surgery.
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[Effects of Tranexamic Acid on Perioperative Blood Loss and Wound Hematoma Development in Lumbar Spine Surgery: a Prospective Randomized Study]
Stejskal, P., Trnka, Š, Hrabálek, L., Wanek, T., Jablonský, J., Novák, V.
Acta chirurgiae orthopaedicae et traumatologiae Cechoslovaca. 2023;90(3):176-180
Abstract
PURPOSE OF THE STUDY Tranexamic acid as a haemostatic agent is commonly used in multiple medical branches. Over the last decade, there has been a steep rise in the number of studies evaluating its effect, i.e. blood loss reduction in specific surgical procedures. The aim of our study was to evaluate the effect of tranexamic acid on reducing intraoperative blood loss, postoperative blood loss into the drain, total blood loss, transfusion requirements, and development of symptomatic wound hematoma in conventional single-level lumbar decompression and stabilization. MATERIAL AND METHODS The study included patients who had undergone a traditional open lumbar spine surgery in the form of single-level decompression and stabilisation. The patients were randomized into two groups. The study group received a 15 mg/kg dose of tranexamic acid intravenously during the induction of anaesthesia and then again 6 hours later. No tranexamic acid was administered to the control group. In all patients, intraoperative blood loss, postoperative blood loss into the drain, and therefore also total blood loss, transfusion requirements and potential development of a symptomatic postoperative wound hematoma requiring surgical evacuation were recorded. The data of the two groups were compared. RESULTS The cohort includes 162 patients, 81 in the study group and the same number in the control group. In the intraoperative blood loss assessment, no statistically significant difference between the two groups was observed; 430 (190-910) mL vs. 435 (200-900) mL. In case of post-operative drain blood loss, a statistically significantly lower volume was reported after the tranexamic acid administration; 405 (180-750) mL vs. 490 (210-820) mL. When evaluating the total blood loss, a statistically significant difference was also confirmed, namely in favour of the tranexamic acid; 860 (470-1410) mL vs. 910 (500- 1420) mL. The reduction of total blood loss did not result in a difference in the number of administered transfusions; transfusions were given to 4 patients in each group. A postoperative wound hematoma requiring surgical evacuation developed in 1 patient in the group with the tranexamic acid and in 4 patients in the control group, but the difference was not statistically significant with respect to the insufficient group size. No patient in our study experienced complications associated with tranexamic acid application. DISCUSSION The beneficial effect of tranexamic acid on reducing blood loss in lumbar spine surgeries has already been confirmed by numerous meta-analyses. The question remains in what types of procedures, at what dose and route of administration its effect is significant. To date, most of the studies have explored its effect in multi-level decompressions and stabilizations. Raksakietisak et al., for instance, report significant reduction in total blood loss from 900 (160, 4150) mL to 600 (200, 4750) mL following an intravenous injection of 2 bolus doses of 15 mg/kg tranexamic acid. In less extensive spinal surgeries, the effect of tranexamic acid may not be that distinct. In our study of single-level decompressions and stabilizations, no reduction in the actual intraoperative bleeding was confirmed at the given dosage. Its effect was seen only in the postoperative period in a significant reduction of blood loss into the drain, thus also in the total blood loss, although the difference between 910 (500, 1420) mL and 860 (470, 1410) mL was not that significant. CONCLUSIONS By intravenous application of tranexamic acid in 2 bolus doses in single-level decompression and stabilization of the lumbar spine a statistically significant reduction in postoperative blood loss into the drain and also total blood loss was confirmed. The reduction in the actual intraoperative blood loss was not statistically significant. No difference was observed in the number of administered transfusions. Following the tranexamic acid administration, a lower number of postoperative symptomatic wound hematomas was recorded, but the difference was not statistically significant. Key words: tranexamic acid, spinal surgeries, blood loss, postoperative hematoma.
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The effect of sequential perioperative intravenous tranexamic acid in reducing postoperative blood loss and hidden blood loss after posterior lumbar interbody fusion: a randomized controlled trial
Dong, W., Liang, Y., Li, D., Ma, Z., Cheng, M., Zhang, X., Shen, J., Zhou, N., Hao, J., Jiang, W., et al
Frontiers in medicine. 2023;10:1192971
Abstract
BACKGROUND Tranexamic acid (TXA) has previously been shown to be effective in reducing intraoperative blood loss (IBL) and transfusion requirements in spine surgery. A conventional TXA regimen is a simple preoperative or intraoperative administration. However, the hyperfibrinolysis caused by surgical trauma lasts at least 24 h, and a single dose of TXA cannot cover the whole process of hyperfibrinolysis. Moreover, its ability to control postoperative blood loss (PBL) may be insufficient. Therefore, this study aimed to explore the effects and safety of sequential perioperative intravenous TXA for reducing bleeding after posterior lumbar interbody fusion (PLIF). METHODS Patients requiring PLIF were randomly divided into two groups. All patients were intravenously injected with 1 g of TXA 15 min before skin resection. Every day after the surgery, 200 ml saline was intravenously injected for 1-3 days in Group A, while Group B received 1 g of TXA instead of saline. The total blood loss (TBL), IBL, PBL, HCT, Hb, blood transfusion volume, inflammation-related indicators, and complications were recorded. RESULTS TBL, PBL, and hidden blood loss (HBL) in Group B were significantly lower than those in Group A (P < 0.05). The maximum decreases in HCT and Hb in Group B were also significantly lower than those in Group A (P < 0.05), and the drainage removal time (DRT) was sooner in Group B than in Group A (P = 0.003). On the 3rd and 5th days after surgery, the level of CRP in Group B was significantly lower than that in Group A (P < 0.05). Similarly, IL-6 levels were significantly lower in Group B for the first 5 days postoperatively (P < 0.001). Sex, operation time, level of decompression, length of incision, and change in HCT were significant predictors of both TBL and HBL. TBL was also significantly associated with BMI and preoperative fibrinogen, while postoperative TXA was a significant predictor of HBL only. CONCLUSION Intravenous injection of 1 g of TXA 15 min before skin resection combined with continuous intravenous injection of 1 g of TXA 1 to 3 days after PLIF can reduce postoperative bleeding and shorten the time to drainage tube removal. In addition, it can also inhibit the postoperative inflammatory response. CLINICAL TRIAL REGISTRATION ChiCTR2200056210.
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Intravenous tranexamic acid for intracerebral meningioma resections: A randomized, parallel-group, non-inferiority trial
Li, S., Liu, M., Yang, J., Yan, X., Wu, Y., Zhang, L., Zeng, M., Zhou, D., Peng, Y., Sessler, D. I.
Journal of clinical anesthesia. 2023;92:111285
Abstract
STUDY OBJECTIVES Tranexamic acid (TXA) is an antifibrinolytic that is widely used to reduce surgical bleeding. However, TXA occasionally causes seizures and the risk might be especially great after neurosurgery. We therefore tested the hypothesis that TXA does not meaningfully increase the risk of postoperative seizures within 7 days after intracranial tumor resections. DESIGN Randomized, double-blind, placebo-controlled, non-inferiority trial. SETTING Beijing Tiantan Hospital, Capital Medical University. PATIENTS 600 patients undergoing supratentorial meningioma resection were included from October 2020 to August 2022. INTERVENTIONS Patients were randomly assigned to a single dose of 20 mg/kg of TXA after induction (n = 300) or to the same volume of normal saline (n = 300). MEASUREMENT The primary outcome was postoperative seizures occurring within 7 days after surgery, analyzed in both the intention-to-treat and per-protocol populations. Non-inferiority was defined by an upper limit of the 95% confidence interval for the absolute difference being <5.5%. Secondary outcomes included incidence of non-epileptic complication within 7 days, changes in hemoglobin concentration, estimated intraoperative blood loss. Post hoc analyses included the types and timing of seizures, oozing assessment, and a sensitivity analysis for the primary outcome in patients with pathologic diagnosis of meningioma. MAIN RESULTS All 600 enrolled patients adhered to the protocol and completed the follow-up for the primary outcome. Postoperative seizures occurred in 11 of 300 (3.7%) of patients randomized to normal saline and 13 of 300 (4.3%) patients assigned to tranexamic acid (mean risk difference, 0.7%; 1-sided 97.5% CI, -∞ to 4.3%; P = 0.001 for noninferiority). No significant differences were observed in any secondary outcome. Post hoc analysis indicated similar amounts of oozing, calculated blood loss, recurrent seizures, and timing of seizures. CONCLUSION Among patients having supratentorial meningioma resection, a single intraoperative dose of TXA did not significantly reduce bleeding and was non-inferior with respect to postoperative seizures after surgery. REGISTRY INFORMATION This trial was registered at clinicaltrials.gov (NCT04595786) on October 22, 2020, by Dr.Yuming Peng.
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The efficacy of temperature intervention combined with tranexamic acid in reducing blood loss and accelerating recovery during spinal fusion
Li, F., Huang, X., Huang, Y., Liang, B., Yin, D.
Medicine. 2023;102(47):e36407
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Abstract
OBJECTIVE This study aimed to evaluate the effect of temperature intervention combined with tranexamic acid (TXA) on perioperative blood loss during spinal fusion and accelerated rehabilitation. METHOD Between August 2014 and July 2019, 310 lumbar fusion at our hospital were randomly divided into 4 groups as follows. Group A (placebo): no TXA and no temperature intervention. Group B: TXA (15 mg/kg) before skin incision. Group C: TXA (15 mg/kg) before skin incision and temperature intervention. Group D: temperature intervention without TXA. The primary outcomes were intraoperative blood loss, postoperative blood loss, total blood loss, and core temperature at different stages. We also recorded the hemoglobin level, blood transfusion rate, prothrombin time on postoperative day 1 (POD1), length of hospital stay, and the incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE). RESULTS The 4 groups showed statistically significant differences in intraoperative blood loss, postoperative blood loss, total blood loss, core temperature after anesthesia, average temperature during the operation, hemoglobin on POD1, and length of stay (P < .05). In contrast, prothrombin time on POD1 and the incidence of DVT or PE did not differ between the groups (P > .05). Comparing the transfusion rate in Group C (6/77, 7.79%) and Group A (17/78, 21.79%), the difference was statistically significant. CONCLUSION Temperature intervention combined with TXA can significantly reduce blood loss and the transfusion rate of spinal fusion in the perioperative period, reduce the length of stay and accelerate rehabilitation after surgery without increasing the incidence of DVT or PE.
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The effect of intravenous unit-dose tranexamic acid on visible and hidden blood loss in posterior lumbar interbody fusion: a randomized clinical trial
Hao, S., Li, H., Liu, S., Meng, S., Zhang, X., Wang, L., Yang, H., Zhang, L., Dong, S.
Scientific Reports. 2023;13(1):4714
Abstract
There are few reports of intravenous unit-dose tranexamic acid (TXA) on the relationship between visible blood loss (VBL) and hidden blood loss (HBL) in posterior lumbar interbody fusion (PLIF). Therefore, the objective of this randomized, prospective, double-blind, single center study was to investigate the effect of intravenous unit-dose TXA on VBL and HBL in patients who underwent PLIF. Among 100 patients, 11 were excluded due to failue to comply with the study, 1 was excluded due to non-conpliance with the study, and 88 were eligible for inclusion in the study. 46 patients who treated with PLIF received unit-dose of TXA (1 g/100 mL) intravenously 15 min before skin incision after general anesthesia (observation group) and 42 patients were given 100 mL of normal saline (control group). The operation time, intraoperative blood loss, postoperative drainage, VBL, HBL, blood transfusion rate, and adverse events were recorded in the two groups. Besides, activated partial prothrombin time (APTT), prothrombin time (PT), thrombin time (TT), fibrinogen (FIB), platelets (PLT), red blood cells (RBC), hemoglobin (HB), hematocrit (HCT), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) on the 1st postoperative day; and RBC, HB, HCT, CRP, ESR on the 4th postoperative day were recorded. All 88 patients successfully completed the operation, the incision healed well, and there was no deep vein thrombosis of the lower extremity after operation. The intraoperative blood loss, postoperative drainage, VBL, HBL, and blood transfusion rate in the observation group were lower than those in the control group, and the differences were statistically significant (p < 0.05). There was no significant difference in operation time between the two groups (p > 0.05). There was no significant difference in postoperative APTT, PT, TT, FIB, PLT, RBC, HB, HCT, CRP and ESR between the two groups (p > 0.05). Intravenous unit-dose TXA is safe and feasible in PLIF, and it can effectively reduce perioperative VBL and HBL.
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Comparison of the effects of tranexamic acid, nitroglycerin, and remifentanil on the prevention of bleeding during herniated lumbar intervertebral disc surgery: A randomized clinical trial
Modir H, Moshiri E, Shakeri A, Khalatbari M
International journal of critical illness and injury science. 2023;13(1):18-25
Abstract
BACKGROUND Surgery is a well-known and effective method of treating lumbar intervertebral disc herniation. The present study aimed to compare the effects of administering tranexamic acid (TXA), nitroglycerin (NTG), and remifentanil (REF) on hemorrhage prevention during herniated lumbar intervertebral disc surgery. METHODS A double-blind clinical trial was conducted on 135 participants undergoing lumbar intervertebral disc surgery. A randomized block design was used for subject assignment to three groups including TXA, NTG, and REF. The hemodynamic parameters, bleeding rate, hemoglobin level, and the amount of infused propofol were measured and recorded after surgery. Data were then analyzed in SPSS software using Chi-square test and analysis of variance. RESULTS The mean age of participants in the study was 42.12 ± 7.93 years, and all three groups were equal in terms of demographic characteristics (P > 0.05). The mean arterial pressure (MAP) of the TXA and NTG groups was notably higher than the REF group (P < 0.008). The mean heart rate (HR) of the TXA and NTG groups was notably higher than the REF group (P < 0.05). The propofol dosage used in the TXA group was higher than the two groups of NTG and REF (P < 0.001). CONCLUSION Among participants undergoing lumbar intervertebral disc surgery, the greatest MAP variability was observed in the NTG group. Higher mean HR and propofol consumption was observed in the NTG and TXA groups when compared to REF. No statistically significant differences were noted between groups in oxygen saturation or bleeding risk. Based on these findings, REF may be considered a preferred surgical adjunct over TXA and NTG during lumbar intervertebral disc surgery.