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Neurology Jun 2024The results of the ULTRA trial showed that ultra-early and short-term treatment with tranexamic acid (TXA) does not improve clinical outcome after aneurysmal... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND AND OBJECTIVES
The results of the ULTRA trial showed that ultra-early and short-term treatment with tranexamic acid (TXA) does not improve clinical outcome after aneurysmal subarachnoid hemorrhage (aSAH). Possibly, the lack of a beneficial effect in all patients with aSAH is masked by antagonistic effects of TXA in certain subgroups. In this post hoc subgroup analysis, we investigated the effect of TXA on clinical outcome in patients with good-grade and poor-grade aSAH.
METHODS
The ULTRA trial was a multicenter, prospective, randomized, controlled, open-label trial with blinded outcome assessment. Participants received ultra-early and short-term TXA in addition to usual care or usual care only. This post hoc subgroup analysis included only ULTRA participants with confirmed aSAH and available World Federation of Neurosurgical Societies (WFNS) grade on admission. Patients were categorized into those with good-grade (WFNS 1-3) and poor-grade (WFNS 4-5) aSAH. The primary outcome was clinical outcome assessed by the modified Rankin scale (mRS). Odds ratios (ORs) and adjusted ORs (aORs) with 95% CIs were calculated using ordinal regression analyses. Analyses were performed using the as-treated principle. In all patients with aSAH, no significant effect modification of TXA on clinical outcome was observed for admission WFNS grade ( = 0.10).
RESULTS
Of the 812 ULTRA participants, 473 patients had (58%; N = 232 TXA, N = 241 usual care) good-grade and 339 (42%; N = 162 TXA, N = 176 usual care) patients had poor-grade aSAH. In patients with good-grade aSAH, the TXA group had worse clinical outcomes (OR: 0.67, 95% CI 0.48-0.94, aOR 0.68, 95% CI 0.48-0.94) compared with the usual care group. In patients with poor-grade aSAH, clinical outcomes were comparable between treatment groups (OR: 1.04, 95% CI 0.70-1.55, aOR 1.05, 95% CI 0.70-1.56).
DISCUSSION
This post hoc subgroup analysis provides another important argument against the use of TXA treatment in patients with aSAH, by showing worse clinical outcomes in patients with good-grade aSAH treated with TXA and no clinical benefit of TXA in patients with poor-grade aSAH, compared with patients treated with usual care.
TRIAL REGISTRATION INFORMATION
ClinicalTrials.gov (NCT02684812; submission date February 18, 2016, first patient enrollment on July 24, 2013).
CLASSIFICATION OF EVIDENCE
This study provides Class II evidence that tranexamic acid, given for <24 hours within the first 24 hours, does not improve the 6-month outcome in good-grade or poor initial-grade aneurysmal SAH.
Topics: Humans; Tranexamic Acid; Subarachnoid Hemorrhage; Female; Antifibrinolytic Agents; Male; Middle Aged; Treatment Outcome; Aged; Prospective Studies; Adult
PubMed: 38788175
DOI: 10.1212/WNL.0000000000209169 -
Neurosurgery May 2024An important proportion of patients with spontaneous intracerebral hemorrhage (ICH) undergo neurosurgical intervention to reduce mass effect from large hematomas and...
The Effect of Tranexamic Acid on Neurosurgical Intervention in Spontaneous Intracerebral Hematoma: Data From 121 Surgically Treated Participants From the Tranexamic Acid in IntraCerebral Hemorrhage-2 Randomized Controlled Trial.
BACKGROUND AND OBJECTIVES
An important proportion of patients with spontaneous intracerebral hemorrhage (ICH) undergo neurosurgical intervention to reduce mass effect from large hematomas and control the complications of bleeding, including hematoma expansion and hydrocephalus. The Tranexamic acid (TXA) for hyperacute primary IntraCerebral Hemorrhage (TICH-2) trial demonstrated that tranexamic acid (TXA) reduces the risk of hematoma expansion. We hypothesized that TXA would reduce the frequency of surgery (primary outcome) and improve functional outcome at 90 days in surgically treated patients in the TICH-2 data set.
METHODS
Participants enrolled in TICH-2 were randomized to placebo or TXA. Participants randomized to either TXA or placebo were analyzed for whether they received neurosurgery within 7 days and their characteristics, outcomes, hematoma volumes (HVs) were compared. Characteristics and outcomes of participants who received surgery were also compared with those who did not.
RESULTS
Neurosurgery was performed in 5.2% of participants (121/2325), including craniotomy (57%), hematoma drainage (33%), and external ventricular drainage (21%). The number of patients receiving surgery who received TXA vs placebo were similar at 4.9% (57/1153) and 5.5% (64/1163), respectively (odds ratio [OR] 0.893; 95% CI 0.619-1.289; P-value = .545). TXA did not improve outcome compared with placebo in either surgically treated participants (OR 0.79; 95% CI 0.30-2.09; P = .64) or those undergoing hematoma evacuation by drainage or craniotomy (OR 1.19 95% 0.51-2.78; P-value = .69). Postoperative HV was not reduced by TXA (mean difference -8.97 95% CI -23.77, 5.82; P-value = .45).
CONCLUSION
TXA was not associated with less neurosurgical intervention, reduced HV, or improved outcomes after surgery.
PubMed: 38785451
DOI: 10.1227/neu.0000000000002961 -
Annals of Emergency Medicine Jun 2024
Topics: Humans; Tranexamic Acid; Antifibrinolytic Agents; Wounds and Injuries; Hemorrhage; Emergencies; Emergency Medical Services
PubMed: 38777505
DOI: 10.1016/j.annemergmed.2024.01.018 -
Frontiers in Neurology 2024Tranexamic acid (TXA) is an antifibrinolytic drug associated with reduced blood loss in a range of surgical specialties. This meta-analysis aimed to compare the efficacy...
BACKGROUND
Tranexamic acid (TXA) is an antifibrinolytic drug associated with reduced blood loss in a range of surgical specialties. This meta-analysis aimed to compare the efficacy and safety of TXA in cervical surgery, focusing on its effects on intraoperative blood loss and related outcomes.
METHODS
We searched the PubMed, EMBASE, Medline, and Cochrane Library databases to identify all literature related to TXA used in cervical spinal surgery. Intraoperative blood loss, postoperative drainage volume, total blood loss, postoperative hematological variables, and complications were analyzed.
RESULTS
Eight trials met the inclusion criteria. The pooled results showed that intraoperative blood loss, total blood loss, and postoperative drainage volume were significantly lower in the TXA group than in the control group. The hemoglobin and hematocrit on postoperative day 1 was significantly higher in the TXA group than in the control group. There was no significant difference in complications between the two groups.
CONCLUSION
The available evidence indicates that TXA effectively reduces blood loss in cervical spinal surgery while maintaining a favorable safety profile, without increasing associated risks.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/, identifier CRD42023459652.
PubMed: 38770522
DOI: 10.3389/fneur.2024.1405773 -
European Journal of Anaesthesiology May 2024Paediatric closed abdominal trauma is common, however, its severity and influence on survival are difficult to determine. No prognostic score integrating abdominal...
BACKGROUND
Paediatric closed abdominal trauma is common, however, its severity and influence on survival are difficult to determine. No prognostic score integrating abdominal involvement exists to date in paediatrics.
OBJECTIVES
To evaluate the severity and short-term and medium-term prognosis of closed abdominal trauma in children, and the performance of severity scores in predicting mortality.
DESIGN
Retrospective, cohort, observational study.
SETTING AND PARTICIPANTS
Patients aged 0 to 18 years presenting at the trauma room of a French paediatric Level I Trauma Centre over the period 2015 to 2019 with an isolated closed abdominal trauma or as part of a polytrauma.
MAIN OUTCOMES
Primary outcome was the six months mortality. Secondary outcomes were related complications and therapeutic interventions, and performance for predicting mortality of the scores listed. Paediatric Trauma Score (PTS), Revised Trauma Score (RTS), Shock Index Paediatric Age-adjusted (SIPA) score, Reverse shock index multiplied by Glasgow Coma Scale score (rSIG), Base Deficit, International Normalised Ratio, and Glasgow Coma Scale (BIG), Injury Severity Score (ISS) and Trauma Score and the Injury Severity (TRISS) score.
DATA COLLECTION
Data collected include clinical, biological and CT scan data at admission, first 24 h management and prognosis. The PTS, RTS, SIPA, rSIG, BIG and ISS scores were calculated and mortality was predicted according to BIG score and TRISS methodology.
RESULTS
Of 1145 patients, 149 met the inclusion criteria and 12 (8.1%) died. Of the 12 deceased patients, 11 (91.7%) presented with severe head injury, 11 (91.7%) had blood products transfusion and 7 received tranexamic acid. ROC curves analysis concluded that PTS, RTS, rSIG and BIG scores accurately predict mortality in paediatric closed abdominal trauma with AUCs at least 0.92. The BIG score offered the best predictive performance for predicting mortality at a threshold of 24.8 [sensitivity 90%, specificity 92%, negative-predictive value (NPV) 99%, area under the curve (AUC) 0.93].
CONCLUSION
PEVALPED is the first French study to evaluate the prognosis of paediatric closed abdominal trauma. The use of PTS, rSIG and BIG scores are relevant from the acute phase and the pathophysiological interest and accuracy of the BIG score make it a powerful tool for predicting mortality of closed abdominal trauma in children.
PubMed: 38769943
DOI: 10.1097/EJA.0000000000002019 -
Journal of Biomedical Materials... May 2024Wound infection and excessive blood loss are the two major challenges associated with trauma injuries that account for 10% of annual deaths in the United States. Nitric...
Wound infection and excessive blood loss are the two major challenges associated with trauma injuries that account for 10% of annual deaths in the United States. Nitric oxide (NO) is a gasotransmitter cell signaling molecule that plays a crucial role in the natural wound healing process due to its antibacterial, anti-inflammatory, cell proliferation, and tissue remodeling abilities. Tranexamic acid (TXA), a prothrombotic agent, has been used topically and systemically to control blood loss in reported cases of epistaxis and combat-related trauma injuries. Its properties could be incorporated in wound dressings to induce immediate clot formation, which is a key factor in controlling excessive blood loss. This study introduces a novel, instant clot-forming NO-releasing dressing, and fabricated using a strategic bi-layer configuration. The layer adjacent to the wound was designed with TXA suspended on a resinous bed of propolis, which is a natural bioadhesive possessing antibacterial and anti-inflammatory properties. The base layer, located furthest away from the wound, has an NO donor, S-nitroso-N-acetylpenicillamine (SNAP), embedded in a polymeric bed of Carbosil®, a copolymer of polycarbonate urethane and silicone. Propolis was integrated with a uniform layer of TXA in variable concentrations: 2.5, 5.0, and 7.5 vol % of propolis. This design of the TXA-SNAP-propolis (T-SP) wound dressing allows TXA to form a more stable clot by preventing the lysis of fibrin. The lactate dehydrogenase-based platelet adhesion assay showed an increase in fibrin activation with 7.5% T-SP as compared with control within the first 15 min of its application. A scanning electron microscope (SEM) confirmed the presence of a dense fibrin network stabilizing the clot for fabricated dressing. The antibacterial activity of NO and propolis resulted in a 98.9 ± 1% and 99.4 ± 1% reduction in the colony-forming unit of Staphylococcus aureus and multidrug-resistant Acinetobacter baumannii, respectively, which puts forward the fabricated dressing as an emergency first aid for traumatic injuries, preventing excessive blood loss and soil-borne infections.
PubMed: 38769626
DOI: 10.1002/jbm.a.37738 -
Orthopaedic Surgery May 2024For elderly femoral neck fracture patients, anemia is one of the most common complications, increasing the risk of postoperative adverse events. Tranexamic acid (TXA)...
OBJECTIVE
For elderly femoral neck fracture patients, anemia is one of the most common complications, increasing the risk of postoperative adverse events. Tranexamic acid (TXA) has been widely applied to the perioperative blood management. However, the optimal route of TXA administration in elderly femoral neck fracture remains unclear. The aim of this study is to evaluate the efficacy and safety of oral and intravenous (IV) application of TXA in elderly patients with femoral neck fracture undergoing total hip arthroplasty (THA) and hemiarthroplasty (HA).
METHODS
All elderly patients aged over 65 years old diagnosed with femoral neck fracture admitted to the trauma orthopedics from August 1, 2020 to February 28, 2022 were enrolled in this prospective cohort study. Participants were divided into three groups: oral group: TXA 2g orally 2 h before incision; IV group: intravenous infusion of TXA 1g 15 min before incision; and control group: usual hemostatic method. The primary outcomes were total blood loss, allogeneic transfusion rate, and postoperative thromboembolic events. SPSS 23.0 (IBM, Armonk, NY, USA) was used for statistical analysis, and p ≤ 0.05 was considered statistically significant.
RESULTS
A total of 100 patients were enrolled, including 32 cases in the oral group, 34 cases in the IV group and 34 cases in the control group. Compared with the control group, the total perioperative blood loss in the oral and IV groups was significantly decreased (763.92 ± 358.64 mL vs 744.62 ± 306.88 mL vs 1250.60 ± 563.37 mL, p = 0.048). No significant difference was identified between the oral and IV groups (p = 0.970). The rate of allogeneic transfusion was lower in the oral and IV groups than in the control group, but the difference had no statistical significant (6 vs 5 vs 12, p = 0.108), However, subgroup analysis showed that the IV and oral groups in patients who underwent THA have significant lower transfusion rate compared with the control group (1 vs 3 vs 7, p = 0.02). During 6 months follow-up, no thromboembolic events were identified. Two patients (one from the oral group and one from the control group) died of respiratory failure. The cost of blood management from the oral group was significantly lower than IV (p < 0.001) and control groups (p = 0.009).
CONCLUSION
Elderly patients with femoral neck fracture undergoing THA can benefit from both IV and oral administration of tranexamic acid. The results of these two administration routes are similar in safety and effectiveness. A similar tendency was observed in patients undergoing HA. Oral TXA is more cost-benefit compared with intravenous applications.
PubMed: 38766813
DOI: 10.1111/os.14089 -
The American Journal of Emergency... May 2024
PubMed: 38760185
DOI: 10.1016/j.ajem.2024.05.012 -
Journal of Plastic, Reconstructive &... Jul 2024Axillary and inguinal lymph node dissections are commonly associated with complications that often require additional interventions.
Reducing the incidence of problematic seroma formation and skin necrosis post-lymphadenectomy: Triple action of topical tranexamic acid, negative pressure wound therapy, and prolonged drainage.
BACKGROUND
Axillary and inguinal lymph node dissections are commonly associated with complications that often require additional interventions.
METHODS
Patients who underwent axillary or inguinal lymphadenectomy via standard procedures were compared to an intervention cohort of patients who underwent axillary or inguinal lymphadenectomy with the use of topical tranexamic acid (TXA) to the wound cavity, a PICO (Smith&Nephew UK) closed-incision negative pressure dressing, and discharged early with a drain in-situ.
RESULTS
Seventy-six patients in the control group (mean age 65.8 years, mean BMI 28.4 kg/m) underwent open lymphadenectomy without topical TXA and a simple dressing. Seventy-eight patients were included in the intervention group (mean age 67.1 years, mean BMI 28.5 kg/m). Patients in the intervention group had an inpatient stay of mean 5.6 days fewer than those in the control group (CI 3.09-5.31; p < .0001), an estimated saving to the healthcare trust of £ 3046.40 (US$3723.61) per patient in "bed days." They had longer drain duration (mean 15 days vs. 8.3 days); however, they had a statistically significant lower risk of seroma formation requiring drainage (6.4% vs. 21%; p = .009), and skin necrosis (0% vs. 6.6%; p = .027). They also had a lower risk of infection (17% vs. 29%), wound dehiscence (15% vs. 25%), and readmission (7.7% vs. 14%), although they were not statistically significant. Patients in the control group were more likely to receive antibiotics as inpatients (51% vs. 7.7%; p < .00001) and on discharge (24% vs. 5%; p < .0011) than those in the intervention group.
CONCLUSIONS
Topical TXA, PICO dressing, and early discharge with a drain following lymphadenectomy results in a reduced rate of complications.
Topics: Humans; Seroma; Negative-Pressure Wound Therapy; Female; Male; Aged; Tranexamic Acid; Lymph Node Excision; Drainage; Postoperative Complications; Necrosis; Administration, Topical; Antifibrinolytic Agents; Axilla; Middle Aged; Skin; Length of Stay; Incidence
PubMed: 38759512
DOI: 10.1016/j.bjps.2024.04.065 -
Journal of Neurosurgery. Spine May 2024Tranexamic acid (TXA) is an FDA-approved antifibrinolytic that is seeing increased popularity in spine surgery owing to its ability to reduce intraoperative blood loss...
Effect of the administration route on the hemostatic efficacy of tranexamic acid in patients undergoing short-segment posterior lumbar interbody fusion: a systematic review and meta-analysis.
OBJECTIVE
Tranexamic acid (TXA) is an FDA-approved antifibrinolytic that is seeing increased popularity in spine surgery owing to its ability to reduce intraoperative blood loss (IOBL) and allogeneic transfusion requirements. The present study aimed to summarize the current literature on these formulations in the context of short-segment instrumented lumbar fusion including ≥ 1-level posterior lumbar interbody fusion (PLIF).
METHODS
The PubMed, Cochrane, and Web of Science databases were queried for all full-text English studies evaluating the use of topical TXA (tTXA), systemic TXA (sTXA), or combined tTXA+sTXA in patients undergoing PLIF. The primary endpoints of interest were operative time, IOBL, and total blood loss (TBL); secondary endpoints included venous thromboembolic complication occurrence, and allogeneic and autologous transfusion requirements. Outcomes were compared using random effects. Comparisons were made between the following treatment groups: sTXA, tTXA, and sTXA+tTXA. Given that sTXA is arguably the standard of care in the literature (i.e., the most common route of administration that to this point has been studied the most), the authors compared sTXA versus tTXA and sTXA versus sTXA+tTXA. Study heterogeneity was assessed with the I2 test, and grouped analysis using the Hedge's g test was performed for measurement of effect size.
RESULTS
Forty-five articles were identified, of which 17 met the criteria for inclusion with an aggregate of 1008 patients. TXA regimens included sTXA only, tTXA only, and various combinations of sTXA and tTXA. There were no significant differences in operative time, TBL, or postoperative drainage between the sTXA and tTXA groups or between the sTXA and sTXA+tTXA groups.
CONCLUSIONS
The present meta-analysis suggested clinical equipoise between isolated sTXA, isolated tTXA, and combinatorial tTXA+sTXA formulations as hemostatic adjuvants/neoadjuvants in short-segment fusion including ≥ 1-level PLIF. Given the theoretically lower venous thromboembolism risk associated with tTXA, additional investigations using large cohorts comparing these two formulations within the posterior fusion population are merited. Although TXA has been shown to be effective, there are insufficient data to support topical or systemic administration as superior within the open PLIF population.
PubMed: 38759242
DOI: 10.3171/2024.2.SPINE23779