-
1.
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.
-
2.
Endoscopic Surgery Versus Stereotactic Aspiration in Spontaneous Intracerebral Hemorrhage Treatment: A Systematic Review and Meta-analysis
Yang, L., Yang, M., He, M., Zhou, X., Zhou, Z.
World neurosurgery. 2024
Abstract
OBJECTIVE To comprehensively compare the safety and efficacy of endoscopic surgery (ES) and stereotactic aspiration (SA) in patients with spontaneous intracerebral hemorrhage (sICH). METHODS We searched Web of Science, PubMed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to July 31, 2023. Studies comparing ES and SA for sICH treatment were also included. Outcome measures included primary outcomes (mortality and good functional outcome (GFO)) and secondary outcomes (evacuation rate, residual hematoma, perihematomal edema (PHE), operation time, volume of intraoperative blood loss, hospital stay duration, intensive care unit (ICU) stay duration, hospital cost, complications, and reoperation). Subgroup analyses assessed the influence of age, hematoma volume, Glasgow Coma Scale (GCS) score, and time to surgery on the outcomes. RESULTS Nine studies (one randomized controlled trial and eight observational studies) with 2105 patients (705 and 1400 in the ES and SA groups, respectively) were included in this meta-analysis. The final analysis indicated that compared with SA, ES was associated with enhanced GFO and a higher evacuation rate 1 d post-surgery along with reduced mortality and residual hematoma. Conversely, ES did not confer benefits in terms of perihematomal edema, operation time, intraoperative blood loss volume, or hospital stay duration compared with SA. Subgroup analysis highlighted the significant influences of age and hematoma volume on mortality, whereas hematoma volume and GCS score affected GFO. CONCLUSIONS ES is a safe and effective approach for sICH treatment, leading to improved patient prognosis and quality of life compared to SA.
-
3.
Topical tranexamic acid (TXA) is non-inferior to intravenous TXA in adult spine surgery: a meta-analysis
Mitha, R., Colan, J. A., Hernandez-Rovira, M. A., Jawad-Makki, M. H., Patel, R. P., Elsayed, G. A., Shaw, J. D., Okonkwo, D. O., Buell, T. J., Hamilton, D. K., et al
Neurosurgical review. 2024;47(1):48
Abstract
Tranexamic acid (TXA) has long been utilized in spine surgery and can be administered through intravenous (IV) and topical routes. Although, topical and IV administration of TXA are both effective in decreasing blood loss during spine surgery, complications like deep vein thrombosis (DVT) and pulmonary embolism have been reported with the use of intravenous TXA (ivTXA). These potential complications may be mitigated through the use of topical TXA (tTXA). To assess optimal dosing protocols and efficacy of topical TXA in spine surgery, Embase, Ovid-MEDLINE, Scopus, Cochrane, and clinicaltrials.gov were queried for original research on the use of tTXA in adult patients undergoing spine surgery. Data parameters analyzed included blood loss, transfusion rate, thromboembolic, and other complications. Data was synthesized and confidence evaluated according to the Grades of Recommendation, Assessment, Development, and Evaluation approach. Nineteen studies were included in the final analysis with 2197 patients. Of the 18 published studies, 9 (50%) displayed high levels of evidence. Topical TXA showed a trend towards a lower risk of transfusion and complications. Protocols that used 1g tTXA showed a significantly reduced risk for transfusion when compared to controls (risk ratio -1.05, 95% CI (-1.62, -0.48); P = 0.94, I(2) = 0%). Complications associated with tTXA included DVTs and wound infections. Topical TXA was non-inferior to intravenous TXA with similar efficacy and complication profiles for bleeding control in spine surgery; however, more studies are needed to discern benefits and risks.
-
4.
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.
-
5.
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.
-
6.
Minimally Invasive Surgery With Thrombolysis for Intracerebral Hemorrhage Evacuation: Bayesian Re-analysis of a Randomized Controlled Trial
Bako, A. T., Potter, T., Pan, A. P., Tannous, J., Britz, G., Ziai, W. C., Awad, I., Hanley, D., Vahidy, F. S.
Neurology. 2023
Abstract
BACKGROUND AND OBJECTIVES Bayesian analysis of randomized controlled trials (RCTs) can extend the value of trial data beyond interpretations based on conventional p-value-based binary cutoffs. We conducted an exploratory post-hoc Bayesian re-analysis of the minimally invasive surgery with thrombolysis for intracerebral hemorrhage (ICH) evacuation (MISTIE-3) trial and derived probabilities of potential intervention effect on functional and survival outcomes. METHODS MISTIE-3 was a multicenter phase-3 RCT designed to evaluate the efficacy and safety of the MISTIE intervention. 506 adults (≥18 years) with spontaneous, non-traumatic, supratentorial ICH of ≥30mL were randomized to receive either the MISTIE intervention (n=255) or standard medical care (n=251). We provide Bayesian-derived estimates of the effect of the MISTIE intervention on achieving a good 365-day Modified Rankin Scale score (mRS score:0-3) as relative risk (RR) and absolute risk difference (ARD), and the probabilities that these treatment effects are greater than pre-specified thresholds. We used two sets of prior distributions: 1) reference priors, including minimally informative, enthusiastic, and skeptical priors; and 2) Data-derived prior distribution, using a hierarchical random-effects model. We additionally evaluated the potential effects of the MISTIE intervention on 180-day and 30-day mRS and 365, 180, and 30-day mortality using data-derived priors. RESULTS The Bayesian-derived probability that MISTIE intervention has any beneficial effect (RR>1) on achieving a good 365-day mRS score was 70% using minimally informative prior, 87% with enthusiastic prior; 68% with skeptical prior; and 73% with data-derived prior. However, these probabilities were ≤ 55% for RR>1.10, and 0% for RR>1.52 across a range of priors. The probabilities of achieving RR>1 for 180 and 30-day mRS scores are 65% and 80% respectively. Furthermore, the probabilities of achieving RR<1 for 365, 180, and 30-day mortality are 93%, 98%, and 99%, respectively. CONCLUSIONS Our exploratory analyses indicate that across a range of priors, the Bayesian-derived probability of MISTIE intervention having any beneficial effect on 365-day mRS for ICH patients is between 68% to 87%. These analyses do not change the frequentist-based interpretation of the trial. However, unlike the frequentist p-values, which indirectly evaluate treatment effects and only provide an arbitrary binary cut-off (such as 0.05), the Bayesian framework directly estimates probabilities of potential treatment effects. TRIAL REGISTRATION https://clinicaltrials.gov/ct2/show/NCT01827046 CLASSIFICATION OF EVIDENCE This study provides Class II evidence that minimally invasive surgery (MIS) + rt-PA does not significantly improve functional outcome in patients with intracerebral hemorrhage. However, The study lacks the precision to exclude a potential benefit of MIS + rt-PA.
-
7.
Effect of Tranexamic Acid on the Reduction of Blood Loss in Craniosynostosis Surgery: A Systematic Review and Meta-analysis
Alabdulkarim, A., Al Qurashi, A. A., Odeh, N. B., Hashemi, A. S. A., Arbili, L. M., AlSwealh, M. S., Shakir, M. N., Banser, S. M., Sharaf, L. A., Alkhonizy, S. W., et al
Plastic and reconstructive surgery. Global open. 2023;11(6):e5021
Abstract
Although many published studies have investigated the benefits of tranexamic acid (TXA) in reducing perioperative bleeding, no large meta-analysis has been conducted to demonstrate its overall benefit. METHODS A systematic review was performed by following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. PubMed, Cochrane, Ovid, Embase, Web of Science, ClinicalTraisl.Gov, and Scopus databases were searched for articles reporting the benefit of TXA in reducing perioperative bleeding in craniosynostosis surgery from establishment through October 2022. The results of our meta-analysis were pooled across the studies using a random-effects model, and presented as a weighted mean difference with 95% confidence interval (95% CI). RESULTS The database search yielded 3207 articles, of which 27 studies with a corresponding number of 9696 operations were eligible. The meta-analysis included only 18 studies, accounting for 1564 operations. Of those operations, 882 patients received systemic TXA, whereas 682 patients received placebo (normal saline), no intervention, low dose TXA, or other control substances. This meta-analysis demonstrated a significant beneficial effect of TXA in reducing perioperative bleeding, particularly when compared with other controlled substances, with a weighted mean difference of -3.97 (95% CI = -5.29 to -2.28). CONCLUSIONS To our knowledge, this is the largest meta-analysis in the literature investigating the benefit of TXA in reducing perioperative blood loss in craniosynostosis surgery. We encourage implementing TXA-protocol systems in hospitals after the appraisal of the data presented in this study.
-
8.
Tranexamic acid use in meningioma surgery - A systematic review and meta-analysis
Clynch AL, Gillespie CS, Richardson GE, Mustafa MA, Islim AI, Keshwara SM, Bakhsh A, Kumar S, Zakaria R, Millward CP, et al
Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia. 2023;110:53-60
Abstract
Tranexamic Acid (TXA) has been used in medical and surgical practice to reduce haemorrhage. The aim of this review was to evaluate the effect of TXA use on intraoperative and postoperative outcomes of meningioma surgery. A systematic review and meta-analysis was conducted in accordance with the PRISMA statement and registered in PROSPERO (CRD42021292157). Six databases were searched up to November 2021 for phase 2-4 control trials or cohort studies, in the English language, examining TXA use during meningioma surgery. Studies ran outside of dedicated neurosurgical departments or centres were excluded. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Random effects meta-analysis were performed to delineate differences in operative and postoperative outcomes. Four studies (281 patients) were included. TXA use significantly reduced intraoperative blood loss (mean difference 315.7 mls [95% confidence interval [CI] -532.8, -98.5]). Factors not affected by TXA use were transfusion requirement (odds ratio = 0.52; 95% CI 0.27, 0.98), operation time (mean difference = -0.2 h; 95% CI -0.8, 0.4), postoperative seizures (Odds Ratio [OR] = 0.88; 95% CI 0.31, 2.53), hospital stay (mean difference = -1.2; 95% CI -3.4, 0.9) and disability after surgery (OR = 0.50; 95% CI 0.23, 1.06). The key limitations of this review were the small sample size, limited data for secondary outcomes and a lack of standardised method for measuring blood loss. TXA use reduces blood loss in meningioma surgery, but not transfusion requirement or postoperative complications. Larger trials are required to investigate the impact of TXA on patient-reported postoperative outcomes.
-
9.
A systematic review and meta-analysis of the effects of tranexamic acid in surgical procedure for intracranial meningioma
Wijaya JH, July J, Quintero-Consuegra M, Chadid DP
Journal of neuro-oncology. 2023
Abstract
PURPOSE During intracranial meningioma surgery, surgeons experience considerable blood loss. Tranexamic acid (TXA) is used to minimize blood loss in several neurosurgical settings. However, evidence and trials are lacking. Our objective is to establish the most recent evidence on TXA safety and efficacy in intracranial meningioma surgery. METHODOLOGY Based upon Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), the authors collected fully published English literature on the administration of tranexamic acid for patients undergoing intracranial meningioma surgery using the keywords ["tranexamic acid" and "meningioma"] and its synonyms from Cochrane Central Database, the WHO International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov, and PubMed. The primary outcome of the current study was total blood loss. The secondary outcomes include individuals requiring blood transfusion, anesthesia duration, surgical duration, and complication rate. Each included studies' quality was assessed using the JADAD scale. RESULTS For qualitative and quantitative data synthesis, we included five RCTs (n = 321) with the mean age was 47.5 ± 11.9 years for the intervention group and 47.2 ± 11.9 years for the control group. Our meta-analysis showed that the administration of TXA is associated with decreased total blood loss of standardized mean difference (SMD) of -1.40 (95% CI [-2.49, -0.31]), anesthetic time SMD -0.36 (95% CI [-0.63, -0.09]), and blood transfusion requirements RR 0.58 (95% CI [0.34, 0.99]). CONCLUSIONS The current study showed that TXA was associated with reduced intraoperative blood loss and intra- and postoperative blood transfusion. However, the studies are small. More RCT studies with a greater sample size are favorable.
-
10.
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.