Abstract

IMPORTANCE Tranexamic acid is widely available and used off-label in patients with bleeding traumatic injury, although the literature does not consistently agree on its efficacy and safety. OBJECTIVE To examine the association of tranexamic acid administration with mortality and thromboembolic events compared with no treatment or with placebo in patients with traumatic injury in the literature. DATA SOURCES On March 23, 2021, PubMed, Embase, and the Cochrane Library were searched for eligible studies published between 1986 and 2021. STUDY SELECTION Randomized clinical trials and observational studies investigating tranexamic acid administration compared with no treatment or placebo among patients with traumatic injury and traumatic brain injury who were 15 years or older were included. Included studies were published in English or German. The electronic search yielded 1546 records, of which 71 were considered for full-text screening. The selection process was performed independently by 2 reviewers. DATA EXTRACTION AND SYNTHESIS The study followed the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data were extracted by 2 independent reviewers and pooled using the inverse-variance random-effects model. MAIN OUTCOMES AND MEASURES Outcomes were formulated before data collection and included mortality at 24 hours and 28 and 30 days (1 month) as well as the incidence of thromboembolic events and the amount of blood products administered. Owing to missing data, overall mortality was added and the amount of blood products administered was discarded. RESULTS Thirty-one studies with a total of 43 473 patients were included in the systematic review. The meta-analysis demonstrated that administration of tranexamic acid was associated with a significant decrease in 1-month mortality compared with the control cohort (risk ratio, 0.83 [95% CI, 0.71-0.97]; I2 = 35%). The results of meta-analyses for 24-hour and overall mortality and thromboembolic events were heterogeneous and could not be pooled. Further investigations on clinical heterogeneity showed that populations with trauma and trial conditions differed markedly. CONCLUSIONS AND RELEVANCE These findings suggest that tranexamic acid may be beneficial in various patient populations with trauma. However, reasonable concerns about potential thromboembolic events with tranexamic acid remain.

Abstract

PURPOSE Analyze the impact of Tranexamic acid (TA) use after percutaneous nephrolithotomy (PNL) on blood loss and transfusion rate (TR), and secondary outcomes, complications rate and stone free rates (SFR), Operative time (OT) and length of hospital stay (LOS). MATERIALS AND METHODS Search made in the Medline (PubMed), Embase, and Central Cochrane for studies published up to August 2021. The study protocol was registered at PROSPERO (CRD42020182197). Eligibility criteria were defined based on PICOS. Articles included were those who assessed the effect of intravenous TA in patients submitted to PNL. Only randomized placebo-controlled trial which included patients with and without TA perioperatively. Results: A total of 1,151 patients were included in 7 studies. Six studies presented a lower blood TR for the TA group (P<0.00001). Four studies presented similar results in relation a lower stone free rate (SFR) (P=0.004), and similar results regarding overall complication rate for the control group (P=0.03). Regarding the 'major complication rate' (Clavien-Dindo ≥3), no difference was found (P=0.07). Four studies showed a higher mean OT for the control group (159 x 151 minutes, respectively, P=0.003). Six studies found a lower mean LOS in the TA group (4.0 x 3.5 days, respectively, P=0.03). CONCLUSIONS The benefit of TXA use in the setting of PCNL perioperative is clear. Our study showed favorable results to TXA use in relation to TR, SFR, complication rate, OT and LOS, but these results did not translate into a lower major complication rate. Further studies evaluating the complexity of the calculi and events unrelated to PCNL may help us to select which patients will benefit from the use of TXA.

Abstract

OBJECTIVES To assess the efficacy and safety of high-dose tranexamic acid (TXA) during bipolar transurethral resection of the prostate (B-TURP) in patients with large prostates compared to placebo. PATIENTS AND METHODS From February 2018 to May 2020, 204 patients with enlarged prostates of 80-130 g and in need of surgical intervention were randomised into two groups. Patients in Group A underwent B-TURP and received TXA as an intravenous loading dose of 50 mg/kg over 20 min before induction of anaesthesia followed by a maintenance infusion of 5 mg/kg/h until resection was completed. The patients in Group B (placebo) received a saline infusion of a similar volume. RESULTS There was highly significant drop in haemoglobin in the placebo group at 4- and 24-h postoperatively compared with the TXA group (P < 0.001). However, there was no significant difference in the blood transfusion rate between the two groups with five patients (5.5%) in the placebo group and four (4.2%) in the TXA group requiring a transfusion (P = 0.74). The procedural time was significantly less in the TXA group vs the control group, at a mean (SD) of 79.93 (22.18) vs 90.91 (21.4) min (P = 0.001). Also, the intraoperative irrigation fluid volume and postoperative irrigation duration were significantly less in the TXA group vs the control group, at a mean (SD) of 19.21 (3.13) vs 23.05 (3.8) L and 14.75 (5.15) vs 18.33 (5.96) h, respectively (P = 0.001). Catheterisation and hospital stay durations were comparable between both groups (P = 0.384 and P = 0.388, respectively). No complications were recorded with use of high-dose TXA. CONCLUSION High-dose TXA was effective in controlling blood loss during B-TURP in patients with large prostates, with no adverse drug reactions.

Abstract

Liposuction remains one of the most frequently performed cosmetic surgical procedures and its popularity is increasing every year. However, since its inception, justified concerns regarding patient safety have placed limits on the volume of fat that can be aspirated, influenced by hemodynamic fluctuations and blood loss during liposuction. Tranexamic acid (TXA) is an antifibrinolytic agent that competitively inhibits the conversion of plasminogen to plasmin, thus preventing the binding and degradation of fibrin. Despite the existence of evidence of the effectiveness of TXA in orthopedic and cardiac surgeries, there is little evidence of its use in liposuction. The objective of this study was to evaluate the efficacy and safety of tranexamic acid in the control of surgical bleeding in patients undergoing liposuction, through a prospective, open, randomized and controlled clinical trial. Two groups of 25 participants each were formed to whom the application of TXA in a tumescent solution prior to liposuction or liposuction with the traditional technique was randomly assigned. The results showed a decrease in blood loss reflected by the differences in the final hematocrit values, as well as decrease in the same per aspirated volume (p = 0.003). No adverse events were found related with the TXA application and no blood transfusions were required in this group, in contrast to the control group where the need for blood transfusion was present in 20% of the intervened participants. LEVEL OF EVIDENCE II This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Abstract

Tranexamic acid (TA) has been proposed for preventing or treating primary postpartum haemorrhage (PPH), which is the leading cause of maternal morbidity and mortality worldwide. We conducted a systematic literature search to the TA role in managing PPH in vaginal and caesarean delivery. Twenty-seven randomised controlled trials (RCTs) (33,302 women) were identified. Three RCTs investigated TA for preventing PPH after vaginal delivery and 22 after caesarean section. None demonstrated a preventive effect on secondary clinical outcomes related to blood loss. Two trials evaluated TA for treating PPH after vaginal and caesarean delivery. Only the WOMAN trial showed that 1 g of TA is effective. In conclusion, TA is considered useful and is recommended or advised for treating PPH. Conversely, available evidence on the prophylactic role is still limited, and this use is not supported. Further investigation is recommended. In this regard, stronger and more reliable outcomes than blood loss should be considered.

Abstract

BACKGROUND Postpartum haemorrhage (PPH) is a major cause of maternal morbidity and mortality worldwide. Tranexamic acid (TXA) is a useful drug for prevention of PPH and merits evaluation in Nigeria, where PPH is the leading cause of maternal death (25%) and severe maternal morbidity. This study evaluates the efficacy of TXA in reducing blood loss following vaginal delivery. METHODS This was a double-blind randomized placebo-controlled study on the efficacy and safety of intravenous TXA in reducing blood loss in women undergoing vaginal delivery in a tertiary hospital. Data analysis was conducted with IBM SPSS software (version 20, Chicago II, USA). P-value < 0.05 was considered statistically significant. RESULTS The mean estimated blood loss was lower in TXA compared with the placebo group. (174.87 ± 119.83 ml versus 341.07 ± 67.97 ml respectively; P < 0.0001). PPH (blood loss > 500 ml) was 5.13% in the study arm compared to the control arm 7.14%- risk ratio (RR) 0.71; 95% CI: 0.38-1.79, p = 0.5956]. Additional uterotonics was required more in the control group compared to the treatment group 14(16.67%) versus 3(3.85%), p-value= 0.007. There were no major complications noticed in the treatment group. CONCLUSION This study demonstrated that intravenous administration of TXA reduced blood loss following vaginal delivery. It also reduced the need for additional uterotonics. However, blood loss greater than 500 was not significantly reduced. TRIAL REGISTRATION This trial was registered retrospectively. Pan African Clinical Trial Registry: PACTR202010828881019 on 12/10/2020.

Abstract

BACKGROUND AND AIMS Clinical trials in chronic inflammatory demyelinating polyneuropathy (CIDP) often assess efficacy using the ordinal Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. Here, data from the PATH study was reanalyzed using change in Inflammatory Rasch-built Overall Disability Scale (I-RODS) to define CIDP relapse instead of INCAT. METHODS The PATH study comprised an intravenous immunoglobulin (IVIG) dependency period and an IVIG (IgPro10 [Privigen®]) restabilization period; subjects were then randomized to weekly maintenance subcutaneous immunoglobulin (SCIG; IgPro20 [Hizentra®]) 0.2 g/kg or 0.4 g/kg or placebo for 24 weeks. CIDP relapse was defined as ≥1-point deterioration in adjusted INCAT, with a primary endpoint of relapse or withdrawal rates. This retrospective exploratory analysis redefined relapse using I-RODS via three different cut-off methods: an individual variability method, fixed cut-off of ≥8-point deterioration on I-RODS centile score or ≥4-point deterioration on I-RODS raw score. RESULTS Relapse or withdrawal rates were 47% for placebo, 34% for 0.2 g/kg IgPro20 and 19% for 0.4 g/kg IgPro20 using the raw score; 40%, 28% and 15%, respectively using the centile score, and 49%, 40% and 27%, respectively using the individual variability method. INTERPRETATION IgPro20 was shown to be efficacious as a maintenance therapy for CIDP when relapse was defined using I-RODS. A stable response pattern was shown for I-RODS across various applied cut-offs, indicating that any could be used in future clinical trials.

Abstract

BACKGROUND The antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage; however, the drug has not been evaluated in a trial in injured children. We evaluated the feasibility of a large-scale trial evaluating the effects of TXA in children with severe hemorrhagic injuries. METHODS Severely injured children (0 up to 18(th) birthday) were randomized into a double-blind randomized trial of 1) TXA 15 mg/kg bolus dose, followed by 2 mg/kg/hr infusion over 8 hours, 2) TXA 30 mg/kg bolus dose, followed by 4 mg/kg/hr infusion over 8 hours, or 3) normal saline placebo bolus and infusion. The trial was conducted at 4 pediatric Level I trauma centers in the United States between June 2018 and March 2020. We enrolled patients under federal exception from informed consent (EFIC) procedures when parents were unable to provide informed consent. Feasibility outcomes included the rate of enrollment, adherence to intervention arms, and ability to measure the primary clinical outcome. Clinical outcomes included global functioning (primary), working memory, total amount of blood products transfused, intracranial hemorrhage progression, and adverse events. The target enrollment rate was at least 1.25 patients per site per month. RESULTS A total of 31 patients were randomized with a mean age of 10.7 years (standard deviation [SD] 5.0 years) and 22 (71%) patients were male. The mean time from injury to randomization was 2.4 hours (SD 0.6 hours). Sixteen (52%) patients had isolated brain injuries and 15 (48%) patients had isolated torso injuries. The enrollment rate using EFIC was 1.34 patients per site per month. All eligible enrolled patients received study intervention (9 patients TXA 15 mg/kg bolus dose, 10 patients TXA 30 mg/kg bolus dose, and 12 patients placebo) and had the primary outcome measured. No statistically significant differences in any of the clinical outcomes were identified. CONCLUSION Based on enrollment rate, protocol adherence, and measurement of the primary outcome in this pilot trial, we confirmed the feasibility of conducting a large-scale, randomized trial evaluating the efficacy of TXA in severely injured children with hemorrhagic brain and/or torso injuries using EFIC.

Abstract

AIM: To determine the most effective administration of tranexamic acid (TXA) in patients with primary total knee arthroplasty (TKA). MATERIAL AND METHOD We enrolled a total of 400 patients (154 men and 346 women) in this randomized trial (4 groups, each of 100 patients). The first group (IV1) had a single intravenous dose (15 mg TXA/kg) prior to skin incision. Group 2 (IV2) had TXA in 2 intravenous doses (15 mg TXA/kg): prior to skin incision and 6 hours after the first dose. Group 3 (TOP) had 2 g TXA in 50 mL of saline irrigated topically at the end of the surgery. The fourth group (COMB) combined IV1 and TOP regimens. We monitored the amount of total blood loss (TBL), haemoglobin drop, use of blood transfusions (BTs), and complications in each patient. RESULTS The amount of TBL was significantly lower in IV1, IV2 and COMB regimens compared to the TOP (P<0.0001). The lowest decrease in haemoglobin within 12 hours after surgery was observed in intravenous regimens (P=0.045). A significant difference in haemoglobin decrease on day 1 after the surgery was demonstrated in the COMB and intravenous regimens (P=0.011). CONCLUSION In primary TKA, it is preferable to administer TXA intravenously in two doses or in a combined regimen. Simple topical administration of TXA was not as effective and is indicated only in cases where systemic administration of TXA is contraindicated. No substantial complications occurred in either group of patients.

Abstract

BACKGROUND Blood loss and incision-related complications caused by the surgical procedure to release gluteal muscle contracture (GMC) put negative effects on the surgical outcomes. Current procedures to prevent blood loss and complications are not satisfactory. The current study aimed to determine whether tranexamic acid (TXA) in combination with pressure dressing reduce the amount of blood loss, the rate of incision-related complications, and the rate of readmission for patients undergoing surgeries to release GMC. METHODS 49 GMC patients were finally included in the study and were randomly divided into two groups: study group and control group. Patients in both groups received minimally invasive surgery to release GMC except that in the study group, patients were administered a dosage of 20 mg/kg of intravenous TXA preoperatively, and 2 subsequent dosages of TXA at 10 mg/kg at two time points: 3 and 6 h after the first dose. Gauze soaked with TXA was used to pack the wound for 10 min before the incision closure. Then the wound was pressure-wrapped with a hip-spica bandage for 24 h after the surgery in the study group. RESULTS The level of UBL in the study group was significantly lower compared to that in the control group. Similar results were also found for UMHD and UMAD. The incision-related postoperative complications were greatly decreased in the study group compared to those of the control group as well. So was the 30-day readmission rate. All patients in both groups reached "excellent" or "good" level with respect to the postoperative function evaluation. CONCLUSIONS Intravenous and topical application of TXA combined with 24 h pressure hip-spica bandage reduces perioperative blood loss, rate of incision-related complications, and the rate of readmission for GMC patients undergoing minimally invasive surgical releasing procedure. Trial Registration Chinese Clinical and Trial Registry ChiCTR2000039216, registration date 2020/10/22, retrospectively registered.