Abstract

Objective: To compare the effectiveness of tranexamic acid (TXA) in reducing blood loss and decreasing surgery duration in craniomaxillofacial surgery. Methods: The literature was searched systematically for all comparative studies of the effect of TXA on craniomaxillofacial surgery with placebo to evaluate the efficacy of TXA in craniomaxillofacial surgery. The primary outcome was intraoperative blood loss, and secondary outcomes were postoperative hematocrit, postoperative hemoglobin, and operation duration. Results: This systematic review included 16 studies consisting of 958 patients. Meta-analysis revealed that compared with the placebo group, the TXA group showed a significant reduction in intraoperative blood loss of 139.81 mL (95% confidence interval, CI: -179.66 to -99.96 mL; p < 0.01), a shortening of the maxillary surgery duration of 15.48 min (95% CI: -21.03 to -9.92 min; p < 0.01), an elevation of the postoperative hemoglobin level of 0.74 mg/dL (95% CI: 0.42 to 1.07 mg/dL; p < 0.01), and a limited effect on increasing the postoperative hematocrit level of 1.77% (95% CI: 0.17 to 3.36; p = 0.03). Conclusion: The use of TXA in craniomaxillofacial surgery can effectively reduce intraoperative blood loss, maintain elevate postoperative hemoglobin and hematocrit levels, and reduce the operation duration.

Abstract

OBJECTIVE To observe the efficacy of intrauterine Bakri balloon tamponade (IBBT) combined with ascending uterine artery ligation (AUAL) in the treatment of postpartum hemorrhage (PPH) due to uterine inertia after cesarean section. METHODS A total of 92 patients with PPH due to uterine inertia after cesarean section were divided into a study group (n=46) and a control group (n=46) in accordance with the random number table. The control group was treated with IBBT alone, while the study group was treated with IBBT combined with AUAL. The clinical efficacies, hemorrhage, surgical duration, hospital stay, hemorrhage rate after removal of tamponade, recurrence rate of PPH, changes in coagulation function and quality of life were compared between the two groups. RESULTS The overall response rate (ORR) in the study group was 95.65%, remarkably higher than that of 80.43% in the control group (P < 0.05). The study group had a lesser amount of hemorrhage at 2 h and 24 h after surgery, a longer surgical duration, a shorter hospital stay, and lower hemorrhage rate after removal of tamponade and recurrence rate of PPH than the control group (P < 0.05). After treatment, prothrombin time, activated partial thromboplastin time and fibrinogen in the study group were markedly higher than those in the control group (P < 0.05). Compared with those before treatment, the scores of quality of life in the two groups were elevated at 3 months after treatment (P < 0.05), and the scores of quality of life in the study group were higher than those in the control group at 3 months after treatment (P < 0.05). CONCLUSION IBBT combined with AUAL can effectively alleviate hemorrhage and improve coagulation function and quality of life of patients with PPH due to uterine inertia after cesarean section, exhibiting a definite efficacy and a high safety profile.

Abstract

OBJECTIVE To investigate whether intensive blood pressure treatment is associated with less hematoma growth and better outcome in ICH patients who received intravenous nicardipine treatment within 2 hrs after onset of symptoms. METHODS A post-hoc exploratory analysis of the Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 (ATACH-2) trial was performed. This was a multicenter, international, open-label randomized clinical trial in which patients with primary ICH were allocated to intensive versus standard blood pressure treatment with nicardipine within 4.5 hours of symptom onset. We have included 913 patients with complete imaging and follow-up data in the present analysis. RESULTS Among the 913 included patients, 354 (38.7%) had intravenous nicardipine treatment initiated within 2 hours. In this subgroup of patients treated within 2 hours, the frequency of ICH expansion was significantly lower in the intensive blood pressure reduction group as compared with standard treatment group (P = 0.02). Multivariable analysis showed that ultra-early intensive blood pressure treatment was associated with a decreased risk of hematoma growth (odds ratio, 0.56; 95% CI, 0.34-0.92; P = 0.02), higher rate of functional independence (odds ratio, 2.17; 95% CI, 1.28-3.68; P = 0.004) and good outcome (OR, 1.68; 95% CI, 1.01-2.83; P = 0.048) at 90 days. Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04). INTERPRETATION In a subgroup of ICH patients with elevated blood pressure given intravenous nicardipine within 2 hours of symptom onset, intensive blood pressure reduction was associated with reduced hematoma growth and improved functional outcome. This article is protected by copyright. All rights reserved.

Abstract

BACKGROUND As Asian populations, Chinese have a lower rate of high-risk gene mutations in venous thrombosis. Therefore, individual patient risk assessment, rather than a "blanket policy", is considered the best thromboembolism prophylaxis for Chinese. The purpose of this study was to evaluate the effectiveness and safety of selective thromboembolism prophylaxis compared with conventional thromboembolism prophylaxis by risk stratification with thromboelastography (TEG) after joint arthroplasty in Chinese. METHODS Between August 2016 to August 2017, Chinese patients who underwent hip or knee arthroplasty were randomly divided into a selective anticoagulation group (SAG) and a conventional anticoagulation group (CAG). Participants and outcome assessors were blinded. In the SAG, an anticoagulant was used when TEG indicated hypercoagulability; while in the CAG, an anticoagulant was regularly used until one month after surgery. Outcome evaluation included effectiveness (defined as the incidence of VTE), and safety (defined as the incidence of bleeding events, poor wound healing, blood loss, and infection). RESULTS A total of 197 patients (79 in the SAG and 118 in the CAG) were included in the study. There was 1 case of deep vein thrombosis (DVT) in the SAG and 2 cases of DVT in the CAG, but there was no significant difference between the two groups. Hidden blood loss in the SAG was 707.4±539.8 mL and hidden blood loss in the CAG was 617±565.0 mL, respectively (P>0.05). No significant difference was observed in perioperative blood loss between the SAG and the CAG (1,024.9±597.9 and 1,139.3±620.9 mL, respectively). Volume of blood transfusion was 92.4±270.2 mL in the SAG and 224.6±416.3 mL in the CAG, respectively, while rate of transfusion was 13.9% in the SAG and 33.9% in the CAG, respectively, which were significantly different between the two groups (P<0.05). CONCLUSIONS In Chinese patients who underwent hip or knee arthroplasty, the efficacy of selective anticoagulation using TEG in risk stratification was comparable to that of conventional anticoagulation. Furthermore, the safety of selective anticoagulant prophylaxis was superior to that of conventional anticoagulant prophylaxis.

Abstract

BACKGROUND Autologous blood transfusion helps to avoid or reduce the need for allogenic blood transfusion in patients undergoing major surgery. We examined the value of erythropoietin therapy to support preoperative autologous blood donation (PABD) in patients undergoing orthopedic surgery. METHODS For this systematic review and meta-analysis, Medline, Cochrane, EMBASE, and Google Scholar databases were searched from October 26th, 1989 until September 30th, 2017. Primary outcomes were percentages of patients able to donate ≥4 units of blood for autologous transfusion, amount of allogeneic blood transfused, changes in hematocrit and hemoglobin levels from before PABD to immediately before surgery, and adverse events. RESULTS Of 256 studies identified, 18 studies met the inclusion criteria with a total of 1914 patients (mean age 51-69 years), of whom 1153 were treated with erythropoietin. Erythropoietin was associated with a greater percentage of patients able to donate ≥4 units of blood for autologous use compared to controls (OR = 6.00, 95% CI = 3.97 to 9.09, P < .001). Patients receiving preoperative erythropoietin had significantly less of a reduction in hematocrit and hemoglobin levels from before PABD to immediately before surgery compared with controls (hematocrit: mean differences = -1.438, 95% CI = -2.14 to -0.73, P < .001; hemoglobin: mean differences = -1.426, 95% CI = -1.78 to -1.07, P < .001). No significant differences were observed in the amount of allogenic blood transfused between patients receiving erythropoietin and controls (difference in means = -0.220, 95% CI = -0.536 to 0.097, P = .174). Patients who received erythropoietin were less likely to experience dizziness than controls, but the incidence of nausea or fatigue were similar between groups. CONCLUSION Erythropoietin therapy during the PABD period results in less of a reduction in hematocrit and hemoglobin levels and an increase in the percentage of patients able to donate blood preoperatively.

Abstract

Tranexamic acid (TXA) reduces surgical blood loss and alleviates inflammatory response in total hip arthroplasty. However, studies have not identified an optimal regimen. The objective of this study was to identify the most effective regimen of multiple-dose oral TXA in achieving maximum reduction of blood loss and inflammatory response based on pharmacokinetic recommendations. We prospectively studied four multiple-dose regimens (60 patients each) with control group (group A: matching placebo). The four multiple-dose regimens included: 2-g oral TXA 2 hours pre-operatively followed by 1-g oral TXA 3 hours post-operatively (group B), 2-g oral TXA followed by 1-g oral TXA 3 and 7 hours post-operatively (group C), 2-g oral TXA followed by 1-g oral TXA 3, 7 and 11 hours post-operatively (group D) and 2-g oral TXA followed by 1-g oral TXA 3, 7, 11 and 15 hours post-operatively (group E). The primary endpoint was estimated blood loss on post-operative day (POD) 3. Secondary endpoints were thromboelastographic parameters, inflammatory components, function recovery and adverse events. Groups D and E had significantly less blood loss on POD 3, with no significant difference between the two groups. Group E had the most prolonged haemostatic effect, and all thromboelastographic parameters remained within normal ranges. Group E had the lowest levels of inflammatory cytokines and the greatest range of motion. No thromboembolic complications were observed. The post-operative four-dose regimen brings about maximum efficacy in reducing blood loss, alleviating inflammatory response and improving analgaesia and immediate recovery.

Abstract

BACKGROUND There is limited information available regarding the clinical management of intravenous immunoglobulin-resistant Kawasaki disease (KD). We aimed to evaluate the optimal treatment options for patients with refractory KD by presenting an indirect-comparison meta-analysis. METHODS PubMed, EMBASE, Web of Science, and the Cochrane Database were searched on August 31, 2018. Unpublished studies were also searched in ProQuest Dissertations & Theses and through manual retrieval strategies. Randomized concurrent controlled trials (RCTs), high-quality non-randomized concurrent controlled trials (non-RCTs), and retrospective studies associated with AEs were included. The quality of all eligible studies was assessed using Cochrane collaboration's tool and non-randomized study guidelines. Risk ratios (RR) with 95% confidence intervals (CIs) for dichotomous outcomes were estimated in our analysis. GRADE profiler 3.6.1 was used to assess the evidence profile. RESULTS Twelve studies involving 372 immunoglobulin-resistant KD patients were identified and analyzed. Neither infliximab nor intravenous pulse methylprednisolone (IVMP) was significantly more effective than second IVIG infusion with respect to lowering coronary artery lesions (CALs) (infliximab, 0.85, 0.43-1.69; IVMP, 0.99, 0.52-1.88) and treatment resistance (infliximab, 0.43, 0.21-0.89; IVMP, 1.16, 0.33-4.13). No significant differences were found between infliximab and IVMP in the incidence rate of CALs (0.70, 0.27-1.81), the treatment resistance (0.37, 0.09-1.60), the rates of coronary artery aneurysm (4.13, 0.38-45.22) and the coronary artery dilatation (0.45, 0.10-1.99). Furthermore, compared with second IVIG infusion, both infliximab and IVMP showed significant effectiveness in antipyretic effects (infliximab, 1.52, 1.16-1.99; IVMP, 1.29, 0.77-2.15). However, Infliximab was noninferior to IVMP on antipyretic effects (1.18, 0.66-2.15). IVMP treatment showed significant association with fewer AEs than second IVIG infusion (0.49, 0.26-0.94) and infliximab (2.34, 1.07-5.09). No significant differences were noted between infliximab treatment and second IVIG infusion (1.06, 0.69-1.63). CONCLUSIONS Infliximab, IVMP, and second IVIG infusion showed no significant differences in the cardioprotective effect or the rate of treatment resistance. Infliximab and IVMP treatment were more effective than second IVIG infusion regarding antipyretic effects. IVMP treatment may have an advantage due to its lower total rate of AEs associated with drug infusion. TRIAL REGISTRATION The study has been registered on PROSPERO ( CRD42016039693 ).

Abstract

OBJECTIVE To study the clinical effect and safety of double filtration plasmapheresis (DFPP) combined with double pulse therapy with methylprednisolone (MP) and cyclophosphamide (CTX) in the treatment of children with severe Henoch-Schonlein purpura nephritis (HSPN). METHODS A total of 60 children with severe HSPN who were admitted to the hospital from January 2014 to March 2018 were enrolled and were randomly divided into an observation group and a control group (n=30 each). In addition to routine treatment, the children in the control group were given MP+CTX pulse therapy. Those in the observation group were given DFPP treatment in addition to the treatment in the control group, with three courses of treatment in total. After three courses of treatment, the two groups were compared in terms of 24-hour urinary protein, urinary microproteins, renal function parameters, adverse reactions, and clinical outcome. RESULTS After three courses of treatment, the observation group had significantly greater reductions in 24-hour urinary protein, urinary albumin, urinary immunoglobulin G, urinary beta2-microglobulin, serum creatinine, and blood urea nitrogen than the control group (P<0.05). After the treatment ended, the observation group had a significantly shorter time to achieve remission than the control group (P<0.05). No serious adverse reactions, such as hemorrhagic cystitis, thrombocytopenia, and hemolysis, were observed, and there was no significant difference in the overall incidence rate of adverse reactions between the two groups (P>0.05). CONCLUSIONS Compared with MP+CTX pulse therapy alone in the treatment of severe HSPN in children, DFPP combined with MP+CTX pulse therapy can further alleviate renal injury and improve clinical outcome and does not increase the incidence rate of adverse reactions.

Abstract

Background: Intertrochanteric fragility fracture (IFF) treated with proximal femoral nail anti-rotation (PFNA) is associated with significant hidden blood loss and high blood transfusion rate. The purpose of the present study was to evaluate the efficacy and safety of tranexamic acid (TXA) in reducing blood loss in these patients. Materials and Methods: Consecutive eligible patients were recruited and randomly assigned to a TXA group or a control group. The TXA group received 15 mg/kg body weight of TXA intravenously 15 min before incision and the same dose 3 h later. The control group received 100 mL of saline intravenously 15 min before incision. The efficacy outcomes included the total perioperative blood loss, postoperative transfusion rate, postoperative hemoglobin level, and length of the hospital stay. The safety outcomes were the incidence of thrombotic events and the mortality rate within 6 weeks after surgery. Results: We had 44 patients in the TXA group and 46 patients in the control group for the final analysis. The TXA group had significantly lower total perioperative blood loss than the control group (384.5 +/- 366.3 mL vs. 566.2 +/- 361.5 mL; P < 0.020). Postoperative transfusion rate was 15.9% in the TXA group versus 36.9% in the control group (P = 0.024). Each group had one patient with postoperative deep venous thrombosis. In the control group, three patients had cerebral infarction, and one patient died within 6 weeks after the operation. Conclusion: Intravenous TXA is effective in reducing total perioperative blood loss and transfusion rate in IFF treated with PFNA. No increased risk of thrombotic events was observed with the use of TXA; however, this study was underpowered for detecting this outcome. Further research is necessary before TXA can be recommended for high-risk patients.

Abstract

BACKGROUND Although randomized controlled trials have confirmed oral tranexamic acid (TXA) can provide similar blood-sparing efficacy compared with intravenous (IV) TXA in total knee arthroplasty (TKA), some concerns do remain about thromboembolic events after such systemic administration. Many studies have confirmed that intra-articular (IA) application of TXA can show similar blood-saving efficacy with minimal levels of systemic absorption compared with IV TXA. However, it remains unclear whether the efficacy and safety of oral TXA administration is equal to or less than that of IA administration in TKA without the use of a tourniquet and drain. Thus, this study was to verify non-inferior efficacy and safety of oral TXA compared with IA TXA in primary TKA. METHODS A double-blind, randomized, controlled trial was performed to compare three oral doses of TXA (2 g of TXA 2 h before incision, and 1 g of TXA 6 and 12 h after surgery, respectively) with IA TXA (3 g of TXA in 100 mL of saline solution). One hundred forty-seven patients scheduled for TKA were randomized to one of the two interventions. The primary outcome was total blood loss. The secondary outcomes included reduction of hemoglobin concentration, clinical outcomes, blood coagulation values, thromboembolic complications, and transfusion rates. RESULTS The mean total blood loss was 788.8 mL in the oral TXA group compared with 872.4 mL in the IA TXA group, with no statistical significance (p > 0.05). There were no significant differences in reduction of hemoglobin level, blood coagulation level, and clinical outcomes. The transfusion rates were 4% in oral group and 5% IA group, respectively. Also, no significant differences were identified in thromboembolic complications. CONCLUSION Oral TXA according to the described protocol demonstrated non-inferiority for primary TKA, with no safety concerns and a greatly reduced cost, compared with the IA TXA. This randomized controlled trial supports the oral administration of TXA in TKA. TRIAL REGISTRATION The trial was registered in the Chinese Clinical Trial Registry ( ChiCTR-INR-17010968 ) dated 23rd March 2017.