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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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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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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.
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The Effect of Topical Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Posterior Lumbar Laminectomy and Discectomy: A Randomized, Double-Blind, Controlled Trial Study
Farzanegan G, Ahmadpour F, Khoshmohabbat H, Khadivi M, Rasouli HR, Eslamian M
Asian spine journal. 2022
Abstract
STUDY DESIGN Randomized, double-blind, controlled trial study. PURPOSE This study aimed to evaluate the safety and efficacy of topical tranexamic acid (TXA) on intraoperative blood loss (IBL) in patients that have degenerative lumbar canal stenosis and undergo posterior lumbar laminectomy and discectomy. OVERVIEW OF LITERATURE The volume of IBL is directly proportional to potential surgical complications. Recent reports have shown that the topical use of antifibrinolytic drugs, such as TXA, during surgery might decrease IBL and improve patient outcomes. METHODS A total of 104 patients with lumbar canal stenosis were enrolled in this randomized, double blinded clinical trial. Participants were randomized and divided into two groups: TXA (54 cases) and control (50 cases). In the TXA group, a TXA solution was used for washing and soaking, whereas, in the control group, irrigation of wound was with normal saline. IBL, pre- and postoperative coagulative studies, operation time, conventional hemostatic agent usage, systemic complications, and length of hospitalization were consecutively recorded. All participants were followed for an additional two months to gather data on their recovery status and time to return to work (RTW). RESULTS At baseline, there was no difference in clinical or lab findings, between the groups. IBL and use of hemostatic agents were significantly decreased in TXA group, as compared to the control group (p=0.001 and p=0.011, respectively). Systemic complications, length of hospitalization, and RTW were not significantly different between groups (p=0.47, p=0.38, and p=0.08, respectively). CONCLUSIONS This study showed that topical use of TXA during surgery may decrease IBL and minimize the use of hemostatic materials during posterior midline-approach laminectomy and discectomy, without increasing the potential for complications seen with intravenous TXA usage.
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[Safety and efficacy of different doses of tranexamic acid in posterior cervical laminectomy with lateral mass screw fixation and bone graft fusion]
Ma, S., Sun, X., Li, L., Tan, Y., Xia, Y.
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi = Zhongguo Xiufu Chongjian Waike Zazhi = Chinese Journal of Reparative and Reconstructive Surgery. 2022;36(12):1506-1511
Abstract
OBJECTIVE To investigate the safety and efficacy of different doses of tranexamic acid (TXA) in posterior cervical laminectomy with lateral mass screw fixation and bone graft fusion by a prospective clinical study. METHODS The middle-aged and elderly patients with cervical spondylotic myelopathy, who were admitted between January 2020 and January 2022 and scheduled to undergo posterior cervical laminectomy with lateral mass screw fixation and bone graft fusion, were studied as the research subjects. Among them, 165 patients met the selection criteria and were included in the study. The patients were allocated into 3 groups ( n=55) by random double-blind lottery. Groups A and B were given intravenous infusion of TXA at 30 minutes before operation according to the standards of 15 and 30 mg/kg, respectively; and group C was given normal saline in the same way. There was no significant difference in gender, age, body mass index, and preoperative D-dimer, hemoglobin (Hb), and hematocrit (HCT) between groups ( P>0.05). The intraoperative bleeding, intraoperative blood transfusion, postoperative drainage volume, drainage days, and postoperative hospital stay were recorded. The Hb, HCT, and D-dimer were compared before operation and at 3 days after operation. Venous ultrasonography of the lower extremities was taken after operation to assess thrombosis; and the postoperative hematoma and epilepsy were also observed. RESULTS All operations were successfully completed, and the incisions healed by first intention. The differences in intraoperative bleeding volume, postoperative drainage volume, drainage days, and postoperative hospital stay between groups were significant ( P<0.05). The above indexes were significantly less in group B than in groups A and C. During operation, 14 patients in group A and 23 patients in group C were transfused, and no patient in group B had blood transfusions. Compared with groups A and C, the blood transfusion volume in group B significantly decreased ( P<0.05), and the difference between groups A and C was not significant ( P>0.05). There was no significant difference in the differences of D-dimer, Hb, and HCT before and after operation between groups ( P>0.05). At 5 days after operation, the venous ultrasonography of the lower extremities showed that the 2 cases of intermuscular venous thrombosis occurred in groups A, B, and C, respectively. No hematoma or epilepsy occurred after operation. CONCLUSION The application of 15 and 30 mg/kg TXA in posterior cervical laminectomy with lateral mass screw fixation and bone graft fusion can reduce intraoperative bleeding and postoperative drainage volume, postoperative drainage days, and postoperative hospital stay. And application of 30 mg/kg TXA can reduce intraoperative blood transfusion, without increasing the risk of lower extremity venous thrombosis, hematoma, and epilepsy.
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Prophylactic administration of tranexamic acid combined with thromboelastography-guided hemostatic algorithm reduces allogeneic transfusion requirements during pediatric resective epilepsy surgery: A randomized controlled trial
Zhang T, Feng H, Xiao W, Li J, Liu Q, Feng X, Qi D, Fan X, Shan Y, Yu T, et al
Frontiers in pharmacology. 2022;13:916017
Abstract
Background: Intraoperative bleeding and allogeneic transfusion remain common problems in pediatric resective epilepsy surgery. Tranexamic acid (TXA) is a widely recommended antifibrinolytic drug that reduces blood loss and transfusion requirements for bleeding patients. Thromboelastography (TEG)-guided hemostatic algorithm is commonly used in bleeding management. This trial was designed to validate the efficacy of a multimodal coagulation therapy involving continuous TXA infusion with TEG-guided hemostatic algorithm in reducing allogeneic exposure risk in pediatric resective epilepsy surgery. Methods: Eighty-three children undergoing resective epilepsy surgery were randomized into a treatment group (Group T; n = 42) and a control group (Group C; n = 41). Group T received prophylactic TXA (10 mg/kg followed by 5 mg/kg/h) with TEG-guided hemostatic algorithm, whereas Group C received conventional coagulation management. The primary outcome was allogeneic transfusion rate during surgery, and the secondary outcomes were intraoperative blood loss, incidence of postoperative seizures, and thromboembolic events during hospitalization. Results: The incidence of intraoperative allogeneic transfusion reduced by 34.7% with the use of a multimodal coagulation therapy (19.0% in Group T vs. 53.7% in Group C; RR 0.355, 95% CI 0.179-0.704; p = 0.001). This was mainly triggered by a significant reduction (44.1%) in intraoperative plasma transfusion (7.1% in Group T vs. 51.2% in Group C; RR 0.139, 95% CI 0.045-0.432; p = 0.000). The risk of intraoperative RBC transfusion was lower in Group T than in Group C, but the difference was not statistically significant (14.3% in Group T vs. 29.3% in Group C; RR 0.488, 95% CI 0.202-1.177; p = 0.098). No platelets were transfused in both groups. Further, 19 (45.2%) patients in Group T received fibrinogen concentrates guided by TEG data, whereas 1 (2.4%) patient in Group C received fibrinogen concentrates empirically. There were no significant differences in estimated blood loss and postoperative seizures between the two groups, and no thromboembolic events were observed after surgery. Conclusion: Prophylactic administration of TXA combined with TEG-guided hemostatic algorithm can be an effective multimodal coagulation strategy for reducing allogeneic transfusion requirements during pediatric resective epilepsy surgery. Clinical Trial Registration: www.chictr.org.cn/index.aspx, identifier ChiCTR1800016188.
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[Prospective randomized controlled trial on the effectiveness of low-dose and high-dose intravenous tranexamic acid in reducing perioperative blood loss in single-level minimally invasive transforaminal lumbar interbody fusion]
Zhang, D., Wu, X., Kong, Q., Wang, Y., Zhang, B., Feng, P., Wu, Y., Guo, C., Li, W.
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi = Zhongguo Xiufu Chongjian Waike Zazhi = Chinese Journal of Reparative and Reconstructive Surgery. 2022;36(4):439-445
Abstract
OBJECTIVE A prospective randomized controlled trial was conducted to study the effectiveness and safety of intravenous different doses tranexamic acid (TXA) in single-level unilateral minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF). METHODS The patients treated with single-level unilateral MIS-TLIF between September 2019 and October 2020 were enrolled and randomly classified into low-dose TXA (LD) group (n=39), high-dose TXA (HD) group (n=39), and placebo-controlled (PC) group (n=38). The LD, HD, and PC groups received intravenous TXA 20 mg/kg, TXA 50 mg/kg, the same volume of normal saline at 30 minute before skin incision after general anesthesia, respectively. There was no significant difference on baseline characteristics and preoperative laboratory results among 3 groups (P>0.05), including age, gender, body mass index, surgical segments, hematocrit (HCT), hemoglobin (HGB), prothrombin time (PT), international normalized ratio (INR), D-dimer, fibrin degradation products (FDP), activated partial prothromboplastin time (APTT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (Cr), urea. The intraoperative blood loss (IBL), postoperative drainage volume, operation time, total blood loss (TBL), hidden blood loss (HBL), blood transfusion, hematological examination indexes on the first day after operation, and the incidence of complications within 1 month were compared among the 3 groups. RESULTS There were 3, 2, and 4 patients in the LD, HD, and PC groups who underwent autologous blood transfusion, respectively, and there was no allogeneic blood transfusion patients in the 3 groups. There was no significant difference in IBL, postoperative drainage volume, and operation time between groups (P>0.05). The TBL, HBL, and the decreased value of HGB in LD and HD groups were significantly lower than those in PC group (P<0.05), and TBL and HBL in HD group were significantly lower than those in LD group (P<0.05); the decreased value of HGB between LD group and HD group showed no significant difference (P>0.05). On the first day after operation, D-dimer in LD and HD groups were significantly lower than that in PC group (P<0.05); there was no significant difference between LD and HD groups (P>0.05). There was no significant difference in other hematological indexes between groups (P>0.05). All patients were followed up 1 month, and there was no TXA-related complication such as deep venous thrombosis of lower extremity, pulmonary embolism, and epilepsy in the 3 groups. CONCLUSION Intravenous administration of TXA in single-level unilateral MIS-TLIF is effective and safe in reducing postoperative TBL and HBL within 1 day in a dose-dependent manner. Also, TXA can reduce postoperative fibrinolysis markers and do not increase the risk of thrombotic events, including deep venous thrombosis and pulmonary embolism.