Tranexamic acid reduces hidden blood loss in the treatment of intertrochanteric fractures with PFNA: a single-center randomized controlled trial.
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ABSTRACT:
SUBMITTER: Lei J
PROVIDER: S-EPMC5558747 | biostudies-other | 2017 Aug
REPOSITORIES: biostudies-other
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Project description:BackgroundTranexamic acid (TXA) is an antifibrinolytic that has been shown to decrease blood loss and transfusion rates after hip and knee arthroplasty, with only limited evidence to support its use in shoulder arthroplasty. This study was conducted to determine whether intravenous (IV) TXA is more effective than placebo in reducing blood loss after primary total shoulder arthroplasty (TSA).MethodsIn this prospective, double-blind, placebo-controlled, randomized clinical trial, patients undergoing primary anatomic and reverse TSA were randomized to receive 1 g of intravenous TXA or a placebo of an equivalent volume of intravenous normal saline administered 10 minutes before the incision. The primary outcome measurement was calculated postoperative blood loss. Secondary outcomes included transfusion rates, weight of hemoglobin loss, hospital length of stay, and thromboembolic events.ResultsThe study enrolled 110 patients, 2 of whom were excluded because they did not have a postoperative hemoglobin measurement, and the remaining 108 patients (52 for TXA, 56 for placebo) were analyzed. There were no significant differences between TXA and placebo groups in preoperative characteristics. For the primary outcome, the TXA group had significantly lower postoperative blood loss of 1100.9 ± 367.4 mL compared with 1274.5 ± 460.0 mL for the placebo group (P = .03). For secondary outcomes, TXA had lower weight of hemoglobin loss compared with placebo (152.2 ± 57.3 g vs. 178.0 ± 65.8 g; P = .03). No patients in the TXA or placebo groups required a transfusion.ConclusionsIntravenous TXA reduced blood loss after primary TSA compared with placebo.
| S-EPMC6334853 | biostudies-literature
Project description:Objective To compare the techniques for the osteosynthesis of intertrochanteric fractures with dynamic hip screws (DHSs) through the Hardinge and minimally-invasive access routes of the hip, evaluating the operative time, the degree of pain in the immediate postoperative period, the hematimetric loss, and the functional aspects of active mobility. Methods A randomized, double-blinded clinical trial in which 66 patients with intertrochanteric fractures were submitted to osteosynthesis by DHS. The patients were divided into a test group, submitted to the minimally-invasive access, and a control group, in whom the surgery was performed through the Hardinge route. Results Patients submitted to the minimally-invasive treatment presented a lower degree of postoperative pain compared to the group treated by the Hardinge lateral route ( p < 0.001), as well as lower hematimetric loss ( p < 0.001), shorter operative time ( p < 0.001), and improvement in immediate postoperative active mobility tests ( p <0.05). Conclusion The study demonstrated the clinical superiority of the minimally-invasive access route parameters analyzed in relation to the Hardinge access for the fixation of intertrochanteric fractures when DHS is the choice osteosynthesis method. Level of evidence I.
| S-EPMC8856856 | biostudies-literature
Project description:BackgroundTranexamic acid (TXA) has been shown to reduce intraoperative bleeding and the need for post-operative allogenic blood transfusion requirement in surgery. In our randomized controlled study, we aimed to evaluate the effect of pre-operative 15 mg/kg intravenous TXA on total blood loss (TBL), hidden blood loss (HBL), and transfusion requirement in elderly patient group with intertrochanteric femoral fracture (ITFF) and treated with proximal femoral nailing (PFN).MethodsPatients diagnosed with ITFFs (AO types 31-A1 and 31-A2) and treated using closed reduction and PFN was divided into two groups in our prospective randomized study. Group 1 (TXA group) was administered 15 mg/kg of TXA 15 min before the incision was made, after anesthesia was given, in the form of an IV infusion in 100 cc of saline. Group 2 (control group) was given only 100 cc of isotonic saline. The primary outcome of the study was TBL. The secondary outcomes were the number of transfusions, HBL, and the surgical (intraoperative) blood loss during the operative procedure and post-operative complications. The outcome values were compared between two groups.ResultsOne hundred and two patients (51 patients in each group) were included in our study. There were no statistically significant differences between the two groups in terms of their demographic characteristics and their pre-operative hemoglobin and hematocrit values. The mean TBL was statistically lower in the TXA group than in the control group (684.6±370.1 ml vs. 971.2±505.3 ml, respectively; p=0.002). The amount of intraoperative blood loss was not significantly different between two groups (102.4±59.3 ml in the TXA group vs. 112.7±90.1 ml in the control group, p=0.67). However, the mean estimated HBL was significantly lower in the TXA group than in the control group (582.3±341.2 ml vs. 857.8±493.1 ml, respectively; p=0.002). The post-operative blood transfusion rate and transfusion unit were found to be significantly lower in the TXA group than in the control group (8% vs. 23.5%, respectively [p=0.033], and 6 U vs. 15 U, respectively [p=0.04]). Both medical and surgical post-operative complications were found to be similar for two groups.ConclusionSingle dose of TXA significantly reduces TBL, HBL, and the need for blood transfusions following PFN in elderly patients with ITFFs, while it does not increase the risk of DVT or thromboembolic events.
| S-EPMC10277341 | biostudies-literature
Project description:BackgroundTranexamic acid (TXA) has been shown to reduce perioperative blood loss in elective orthopedic surgery. The safety of intravenous TXA in nonelective hip fracture surgery is uncertain. The purpose of this study was to evaluate the efficacy and safety of topical TXA in hip fracture surgery.MethodsAdult patients presenting to a community hospital with a hip fracture requiring surgery were randomly assigned to receive topical TXA or placebo. Hemoglobin and troponin I levels were measured preoperatively and on postoperative days 1, 2 and 3. All postoperative blood transfusions were recorded. Complications, including acute coronary syndrome (ACS), venous thromboembolism (VTE), cerebrovascular accidents (CVA), surgical site infections (SSI) and 90-day mortality, were recorded.ResultsData were analyzed for 65 patients (31 in the TXA group, 34 in the control group). Hemogloblin level was significantly higher on postoperative days 1 and 2 in the TXA group than in the control group. The difference in hemoglobin level between the groups was not statistically significant by postoperative day 3. Significantly fewer units of packed red blood cells were transfused in the TXA group (2 units v. 8 units); however, 2 of the units in the control group were given intraoperatively, and when these were excluded the difference was not significant. The incidence of ACS, CVA, VTE, SSI, transfusion and all-cause mortality at 90 days did not differ significantly between the groups.ConclusionTopical TXA reduces early postoperative blood loss after hip fracture surgery without increased patient risk.Trial registrationClinicaltrials.gov, no. NCT02993341.
| S-EPMC8519492 | biostudies-literature
Project description:BACKGROUND:An incentive spirometer (IS) is a mechanical device that promotes lung expansion. It is commonly used to prevent postoperative lung atelectasis and decrease pulmonary complications after cardiac, lung, or abdominal surgery. This study explored its effect on lung function and pulmonary complication rates in patients with rib fractures. METHODS:Between June 2014 and May 2017, 50 adult patients with traumatic rib fractures were prospectively investigated. Patients who were unconscious, had a history of chronic obstructive pulmonary disease or asthma, or an Injury Severity Score (ISS) ≥ 16 were excluded. Patients were randomly divided into a study group (n = 24), who underwent IS therapy, and a control group (n = 26). All patients received the same analgesic protocol. Chest X-rays and pulmonary function tests (PFTs) were performed on the 5th and 7th days after trauma. RESULTS:The groups were considered demographically homogeneous. The mean age was 55.2 years and 68% were male. Mean pretreatment ISSs and mean number of ribs fractured were not significantly different (8.23 vs. 8.08 and 4 vs. 4, respectively). Of 50 patients, 28 (56%) developed pulmonary complications, which were more prevalent in the control group (80.7% vs. 29.2%; p = 0.001). Altogether, 25 patients had delayed hemothorax, which was more prevalent in the control group (69.2% vs. 29.2%; p = 0.005). Two patients in the control group developed atelectasis, one patient developed pneumothorax, and five patients required thoracostomy. PFT results showed decreased forced vital capacity (FVC) and forced expiratory volume in 1 s (FEV1) in the control group. Comparing pre- and posttreatment FVC and FEV1, the study group had significantly greater improvements (p < 0.001). CONCLUSIONS:In conclusion, the use of an IS reduced pulmonary complications and improved PFT results in patients with rib fractures. The IS is a cost-effective device for patients with rib fractures and its use has clinical benefits without harmful effects. TRIAL REGISTRATION:ClinicalTrials.gov, NCT04006587. Registered on 3 July 2019.
| S-EPMC6937666 | biostudies-literature
Project description:(1) Background: the purpose of this study was to investigate the efficacy and safety of intravenous (IV) administration of tranexamic acid (TXA) in patients undergoing medial opening wedge high tibial osteotomy (MOWHTO). (2) Methods: a total of 73 patients were randomly allocated into two groups (TXA group and control group). The primary outcome was total perioperative calculated blood loss after MOWHTO. Secondary outcomes included self-reported pain severity using a 10-point visual analog scale (VAS) and the EuroQol-5 Dimension (EQ-5D) questionnaire. The postoperative allogeneic transfusion rate and wound complications were compared. Deep vein thrombosis (DVT) incidence was compared by conducting DVT computed tomography imaging. (3) Results: the total blood loss after surgery was 470.9 mL in the TXA group and 739.3 mL in the control group, showing a significant difference (p < 0.001). There were no differences in pain VAS scores between the two groups (all p > 0.05). No difference in preoperative EQ-5D scores for any items existed between the two groups. No transfusion was performed in either group. There was no difference in DVT incidence or the rate of wound complications between the two groups. (4) Conclusion: in patients undergoing MOWHTO, IV TXA reduces total blood loss and drainage amount. However, no additional benefits in clinical outcomes, transfusion rate, or wound complications were apparent, with similar DVT incidence rates.
| S-EPMC8347076 | biostudies-literature
Project description:BackgroundTotal knee arthroplasty (TKA) is associated with a significant blood loss. Several methods have been reported to reduce postoperative blood loss and avoid homologous blood transfusions. In this study, we investigated the efficacy of temporary clamping of the drain either or not in combination with tranexamic acid administration for controlling blood loss after TKA.MethodsThe prospective, randomized, and double-blinded study was conducted in our institute. Total of 240 patients, who diagnosed primary osteoarthritis and scheduled to undergo a primary TKA,,were randomized into one of the four groups: Group A or control group, the drain was not clamped and the patient received a placebo; Group B, the drain was not clamped and the patient received tranexamic acid; Group C, the drain was clamped and the patient received a placebo; and Group D, the drain was clamped and the patient received tranexamic acid. The volume of drained blood at 48 hours postoperatively, the decreasing of hemoglobin (Hb) level at 12 hours postoperatively and the number of patients requiring blood transfusion were recorded and compared.ResultsThe mean postoperative volumes of drained blood and the amount of blood transfusion in the three study groups (group B, C and D) were significantly lower than those in the control group (p < 0.05), which group D had the lowest values. Furthermore, group B and D could maintain the Hb level better than group A and C (p < 0.001). In terms of blood transfusions rate, although the patients in group D required transfusion less than group A and C (p < 0.05), there was no significant difference between group D and B. The relative risks for transfusion requirement were 4.4 for group A, 1.4 for group B and 3.0 for group C when compared to group D.ConclusionsThe clamping of drain combined with tranexamic acid administration could reduce postoperative blood loss and blood transfusion after TKA, significantly greater than using tranexamic acid or drain clamping alone.Trial registrationClinicalTrials.gov NCT01449552.
| S-EPMC3416573 | biostudies-literature
Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.
2024-06-13 | PXD046061 | Pride
Project description:BackgroundIntravenous tranexamic acid (IV TXA) is one of the most effective agents in use for reducing blood loss following total knee arthroplasty (TKA) but its safety regarding venous thromboembolic events (VTEs) remains in question. The direct, local application of TXA may reduce systemic toxicity whilst maintaining good or better bleeding control compared to IV TXA. The topical application of TXA via Hemovac drains has been reported previously with good results. However, there are no data on peri-articular TXA injections during TKA.MethodsWe conducted an open randomized, pilot study of peri-articular vs. IV TXA in 60 patients undergoing TKA. 30 patients received either: (i) 750 mg peri-articular TXA into the medial, lateral capsules and the quadriceps tendon prior to capsular closure and tourniquet deflation (group1), or (ii) 750 mg of IV TXA just before tourniquet deflation. Blood loss in the hemovac drain and hemoglobin (Hb) concentrations were measured at 24 and 48 h (h), and the number of blood transfusions and leg circumference measurements were recorded.ResultsAt 48 h, the total blood loss in the hemovac drain was 445 mL in group 1 vs. 520 mL in group 2 (p = 0.081) and the corresponding declines in Hb were 1.85 g/dL vs. 1.87 g/dL (p = 0.84). 16 patients received blood transfusions: 9 vs. 7 in groups 1 and 2, respectively (p = 0.928). There were no differences in thigh and lower leg circumferences, pain scores, knee flexion at discharge date and lengths of hospital stay. There were no clinically detected venous thromboembolic events.ConclusionThis pilot study has shown promising results for peri-articular TXA during TKA. Additional, larger studies are needed to confirm our results and be powered to show differences in efficacy and safety of peri-articular vs. IV TXA.Trial registrationClinicalTrials.gov Identifier NCT02829346 . Retrospectively registered: 07/11/2016.
| S-EPMC4960744 | biostudies-literature
Project description:BACKGROUND:Evidence increases that a high or a standard dose of tranexamic acid (TA) reduces postpartum bleeding. The TRACES pharmacobiological substudy aims to establish a therapeutic strategy in hemorrhagic (H) Cesarean section (CS) with respect to the intensity of fibrinolysis by using innovative assays. METHOD/DESIGN:The TRACES trial is a multicenter, randomized, double-blind, placebo-controlled, TA dose-ranging study that measures simultaneously plasmatic and uterine and urine TA concentrations and the plasmin peak inhibition tested by a simultaneous thrombin plasmin generation assay described by Van Geffen (novel hemostasis assay [NHA]). Patients undergoing H CS (>800 mL) will receive blindly TA 0.5 g or 1 g or placebo. A non-hemorrhagic (NH) group will be recruited to establish plasmin generation profile. Venous blood will be sampled before, at the end, and then at 30, 60, 120, and 360 min after injection. Uterine bleeding will be sampled after injection. Urine will be sampled 2 h and 6 h after injection. The number of patients entered into the study will be 114 H + 48 NH out of the 390 patients of the TRACES clinical trial. DISCUSSION:To explore the two innovative assays, a preliminary pilot study was conducted. Blood samples were performed repeatedly in patients undergoing either a H (>800 mL) or NH (<800 mL) CS and in non-pregnant women (NP). H patients received TA (0-2 g). Dose-dependent TA plasmatic concentrations were determined by LC-MS/MS quantification. Plasmin generation and its inhibition were tested in vitro and in vivo using the simultaneous thrombin-plasmin generation assay (STPGA). The pilot study included 15 patients in the H group, ten patients in the NH group, and seven patients in the NP group. TA plasmatic concentration showed a dose-dependent variation. STPGA inter-assay variation coefficients were < 20% for all plasmin parameters. Inter-individual dispersion of plasmin generation capacity was higher in H and NH groups than in NP group. Profile evolution over time was different between groups. This preliminary technical validation study allows TRACES pharmacobiological trial to be conducted. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02797119. Registered on 13 June 2016.
| S-EPMC5831219 | biostudies-literature