Abstract

BACKGROUND Coronavirus disease 2019 (COVID-19) is associated with coagulopathy but the optimal prophylactic anticoagulation therapy remains uncertain and may depend on COVID-19 severity. OBJECTIVE To compare outcomes in hospitalized adults with severe COVID-19 treated with standard prophylactic versus intermediate dose enoxaparin. METHODS We conducted a multi-center, open-label, randomized controlled trial comparing standard prophylactic dose versus intermediate dose enoxaparin in adults who were hospitalized with COVID-19 and admitted to an intensive care unit (ICU) and/or had laboratory evidence of coagulopathy. Patients were randomly assigned in a 1:1 ratio to receive standard prophylactic dose enoxaparin or intermediate weight-adjusted dose enoxaparin. The primary outcome was all-cause mortality at 30 days. Secondary outcomes included arterial or venous thromboembolism and major bleeding. RESULTS A total of 176 patients (99 males and 77 females) underwent randomization. In the intention-to-treat population, all-cause mortality at 30 days was 15% for intermediate dose enoxaparin and 21% for standard prophylactic dose enoxaparin (odds ratio, 0.66; 95% confidence interval, 0.30-1.45; P=0.31 by chi-square test). Unadjusted Cox proportional hazards modeling demonstrated no significant difference in mortality between intermediate and standard dose enoxaparin (hazard ratio, 0.67; 95% confidence interval, 0.33 to 1.37; P=0.28). Arterial or venous thrombosis occurred in 13% of patients assigned to intermediate dose enoxaparin and 9% of patients assigned to standard dose enoxaparin. Major bleeding occurred in 2% of patients in each arm. CONCLUSION In hospitalized adults with severe COVID-19, standard prophylactic dose and intermediate dose enoxaparin did not differ significantly in preventing death or thrombosis at 30 days.

Abstract

AIMS: The aim of this study was to investigate the hypothesis that a single dose of tranexamic acid (TXA) would reduce blood loss and transfusion rates in elderly patients undergoing surgery for a subcapital or intertrochanteric (IT) fracture of the hip. METHODS In this single-centre, randomized controlled trial, elderly patients undergoing surgery for a hip fracture, either hemiarthroplasty for a subcapital fracture or intramedullary nailing for an IT fracture, were screened for inclusion. Patients were randomly allocated to a study group using a sealed envelope. The TXA group consisted of 77 patients, (35 with a subcapital fracture and 42 with an IT fracture), and the control group consisted of 88 patients (29 with a subcapital fracture and 59 with an IT fracture). One dose of 15 mg/kg of intravenous (IV) TXA diluted in 100 ml normal saline (NS,) or one dose of IV placebo 100 ml NS were administered before the incision was made. The haemoglobin (Hb) concentration was measured before surgery and daily until the fourth postoperative day. The primary outcomes were the total blood loss and the rate of transfusion from the time of surgery to the fourth postoperative day. RESULTS Homogeneity with respect to baseline characteristics was ensured between groups. The mean total blood loss was significantly lower in patients who received TXA (902.4 ml (-279.9 to 2,156.9) vs 1,226.3 ml (-269.7 to 3,429.7); p = 0.003), while the likelihood of requiring a transfusion of at least one unit of red blood cells was reduced by 22%. Subgroup analysis showed that these differences were larger in patients who had an IT fracture compared with those who had a subcapital fracture. CONCLUSION Elderly patients who undergo intramedullary nailing for an IT fracture can benefit from a single dose of 15 mg/kg TXA before the onset of surgery. A similar tendency was identified in patients undergoing hemiarthroplasty for a subcapital fracture but not to a statistically significant level. Cite this article: Bone Joint J 2021;103-B(3):442-448.

Abstract

OBJECTIVE Transurethral resection of the prostate (TURP) is a common procedure for the treatment of benign prostatic hyperplasia (BPH). Previous studies on the effect of 5-alpha reductase inhibitors on perioperative blood loss in TURP and microvessel density (MVD) in the prostate are equivocal. We evaluated whether pretreatment with finasteride for 2 weeks before surgery can reduce perioperative blood loss in TURP and MVD in the prostate. MATERIALS AND METHODS Sixty-eight patients of BPH planned for TURP were randomized into two groups. The study group comprising 34 patients was treated with finasteride (5 mg/day) for 2 weeks and the placebo group comprising 34 patients received placebo for 2 weeks, before TURP. Blood loss was measured in terms of a reduction in the blood hemoglobin (Hb) and hematocrit (HCT) levels between preoperative values and 24 h after surgery. MVD was measured in the resected prostate tissue stained with anti-CD31 monoclonal antibody. RESULTS The reduction of Hb and HCT in the finasteride group was significantly lower than the reduction in the placebo group (P < 0.05). The artery (P = 0.005), vein (P = 0.05), and gland (P = 0.008) densities were significantly less in the finasteride group than in the placebo group. There was no significant correlation between blood loss and MVD. CONCLUSIONS Our study suggests a clear advantage of the preoperative use of finasteride for 2 weeks by reducing the perioperative blood loss in TURP in patients with BPH. While there is a significant reduction in MVD in the prostate on treatment with finasteride, it is not clear that this is the mechanism of reduction in blood loss in TURP.

Abstract

OBJECTIVES There is great interest in developing and studying novel therapies for epistaxis in hereditary hemorrhagic telangiectasia (HHT) given its associated morbidity and impact on patients' quality of life. Several recent randomized controlled trials (RCTs) have been negative, likely attributed to poorly characterized outcome measures. This study reported on and evaluated an epistaxis outcome measure, weekly epistaxis duration (WED) in an ongoing RCT, with the aim of better characterizing the measurement of epistaxis for clinical trials. MATERIALS AND METHODS Patients were recruited to an ongoing phase II, double-blind, cross-over RCTs of oral doxycycline for HHT-associated epistaxis. Patients were included for the epistaxis measures analysis if they had already completed the initial 3-month run-in period, and had received treatment of either study drug doxycycline or placebo for a minimum of 6 months. The primary measure of interest was patient-reported outcome (PRO)-WED, captured from prospective daily diaries. Epistaxis severity score (ESS) was collected as a secondary outcome. RESULTS Seven patients were included for analysis, with 98% completion of the daily diary. The average PRO-WED across all patients was 85.0 minutes, SD 93.2 at baseline, and 65.6 minutes, SD 59.5 during treatment/placebo. Coefficient of variance for PRO-WED at baseline and during treatment/placebo was 0.49, SD 0.1 and 0.58, SD 0.2, respectively. Statistically significant changes in the mean PRO-WED from baseline to treatment/placebo was noted in six patients (86%). Only two patients (29%) had a significant change in ESS, with both reporting decreased (improved) scores after treatment/placebo as compared to baseline. CONCLUSIONS PRO-WED was a feasible clinical trials measure, was reasonably stable during baseline measurement, and appeared to be variable with treatment state, suggesting it may provide a sensitive clinical trials PRO in HHT.

Abstract

INTRODUCTION A novel type of a disposable circumcision suture device (DCSD) has been proved to be effective and safe; however, a few cases of severe bleeding took place after circumcisions. AIM: To evaluate the effectiveness of a modified double-layer pressure dressing to avoid severe bleeding after circumcision with the DCSD, in our department in a prospective randomized controlled study, and discuss the mechanism of bleeding with DCSD. METHODS Patients with redundant foreskin or phimosis were included between September 2018 and November 2019 and divided into 2 groups: In group A, the conventional pressure dressing was performed; in group B, an modified double-layer pressure dressing was performed. MAIN OUTCOME MEASURE The main outcomes and complications (surgical time, incidence of glans ischemia, severe bleeding rate, infection rate, pain level, total cost, and overall satisfaction) were collected and analyzed. RESULTS A total of 624 patients were recruited for this study. There was no difference in the average age and body mass index between 2 groups. No patient suffered obvious glans ischemia. In group B, lower pain level, lower incidences of severe bleeding, and better satisfaction were recorded. CONCLUSION The mechanism of bleeding with the DCSD was discussed in this study, and the modified pressure dressing was proved effective, safe, and easy to perform. W Jiang, J-li Fu, W-l Guo, et al. A Modified Pressure Dressing to Avoid Severe Bleeding After Circumcision With a Disposable Circumcision Suture Device and a Discussion on the Mechanism of Bleeding With the Disposable Circumcision Suture Device. Sex Med 2020;XX:XXX-XXX.

Abstract

BACKGROUND Periodontal regeneration remains one of the crucial issues in the field of periodontology. Periodontal intrabony defects could be treated by surgical intervention through various alloplastic bone graft substitutes. The Food and Drug Administration approved, Novabone putty is one of the recently marketed bone graft substitutes, which has been used in the present study. This study also incorporates the placement of platelet-rich fibrin (PRF) in combination with Novabone putty. MATERIALS AND METHODS Twenty patients were included in the study and were allocated to either Group A or Group B through randomization. Group A included the placement of Novabone putty in the periodontal intrabony defects, whereas Group B included the placement of Novabone putty along with PRF. Statistical analysis of plaque index, gingival index, probing pocket depth, relative attachment level, and intraoral periapical radiographs was performed. RESULTS Statistical more significant difference (P < 0.05) in probing pocket depth, and relative attachment level was observed in Group B (Novabone putty and PRF) in comparison to Group A (Novabone putty). CONCLUSION Evaluation of efficacy of Novabone putty along with PRF produced more favorable results in relative attachment level gain and more reduction in probing pocket depth when compared to Novabone putty alone.

Abstract

BACKGROUND The role of injectable platelet rich fibrin (i-PRF) in orthodontic treatment has not been investigated with focus on its effect on dental and bony periodontal elements. OBJECTIVE To evaluate the efficacy of i-PRF in bone preservation and prevention of root resorption. METHODS A randomized split-mouth controlled trial included 21 patients aged 16-28 years (20.85 ± 3.85), who were treated for Class II malocclusion with the extraction of the maxillary first premolars. Right and left sides were randomly allocated to either experimental treated with i-PRF or control sides. After the leveling and alignment phase, the canines were retracted with 150gm forces. The i-PRF was prepared from the blood of each patient following a precise protocol, then injected immediately before canine retraction on the buccal and palatal aspects of the extraction sites. Localized maxillary cone beam computed tomography scans were taken before and after canine retraction to measure alveolar bone height and thickness and canine root length (indicative of root resorption), and the presence of dehiscence and fenestration. Paired sample t-tests and Wilcoxon signed rank tests were used to compare the changes between groups. RESULTS No statistically significant differences in bone height, bone thickness were found between sides and between pre- and post-retraction period. However, root length was reduced post retraction but did not differ between sides. In both groups, postoperative dehiscence was observed buccally and palatally and fenestrations were recorded on only the buccal aspect. CONCLUSIONS I-PRF did not affect bone quality during canine retraction or prevent canine root resorption. I-PRF did not reduce the prevalence of dehiscence and fenestration. Trial registration ClinicalTrials.gov (identifier number: NCT03399760. 16/01/2018).

Abstract

BACKGROUND To explore the effects of isovolumic hemodilution and platelet-rich plasma separation on platelet activation state and function, complications, and inflammation in patients undergoing cardiac surgery. METHODS A total of 80 patients who needed cardiac surgery under extracorporeal circulation from February 2018 to December 2019 in our hospital were selected as research subjects and divided into observation group (n = 40) and control group (n = 40) according to the random number table method. The patients in the observation group underwent platelet-rich plasma separation, while those in control group received acute isovolumic hemodilution. Then the platelet activation state and functional indexes, hemorheological indexes, and the coagulation functional indexes were compared between the two groups of patients before operation. Next, the changes in the levels of hemoglobin and high-sensitivity C-reactive protein (hs-CRP), an inflammatory factor, during blood protection (before and at 6 hours and 12 hours after intervention) were analyzed. Moreover, the dosage of blood products during operation was compared between the two groups, and postoperative complications and recovery in the two groups were statistically assessed. RESULTS Before operation, the platelet adherence rate and aggregation rate in the observation group were significantly higher than those in control group (p < 0.05), while R and K values in thromboelastograms in the former were notably smaller than those in the latter (p < 0.05). Meanwhile, the whole blood low-shear viscosity, whole blood high-shear viscosity, and plasma viscosity in observation group were remarkably lower than those in control group (p < 0.05). In addition, the observation group exhibited shorter prothrombin time (PT), thrombin time (TT), and activated partial thromboplastin time (APTT) (p < 0.05) and a higher fibrinogen (Fib) level (p < 0.05) than the control group. At 6 hours and 12 hours after intervention and before operation, the hemoglobin level in observation group was markedly higher than that in control group (p < 0.05). In addition, the dosages of red blood cells, fresh frozen plasma, and platelets among blood products during operation in the observation group were evidently lower than those in the control group (p < 0.05), and the number of cases of hemorrhage, pulmonary infection, coagulation dysfunction, and paraplegia after operation in the former was distinctly smaller than that in the latter (p < 0.05). Furthermore, the observation group had an obviously smaller postoperative 24 hours drainage volume (p < 0.05) as well as shorter postoperative mechanical ventilation time and ICU treatment time than control group (p < 0.05). CONCLUSIONS For patients undergoing cardiac surgery under extracorporeal circulation, platelet-rich plasma separation and reinfusion technology can effectively ensure platelet activation state and function, reduce blood viscosity, ensure stable coagulation function, elevate hemoglobin level and decrease inflammatory reaction, and perioperative allogeneic blood infusion, with fewer adverse reactions in treatment, thus efficaciously facilitating the post-operative recovery of patients.

Abstract

BACKGROUND Uncontrolled bleeding after cardiac surgery can be life-threatening. Factor eight inhibitor bypassing activity (FEIBA) is a prothrombin complex concentrate empirically used as rescue therapy for correction of refractory bleeding diathesis post-cardiopulmonary bypass (CPB). FEIBA used as rescue therapy for bleeding diathesis after CPB has been associated with a low incidence of complications and a reduction in transfusion requirement and re-exploration. The feasibility and efficacy of early administration of FEIBA after the termination of CPB have not been studied in a prospective randomized trial. METHODS We designed a small randomized, double-blinded, placebo-controlled pilot trial to determine the feasibility of a larger trial testing the hypothesis that FEIBA decreases transfusion requirements after CPB. The study was designed to evaluate the feasibility of a larger pivotal trial to determine the effectiveness of FEIBA in reducing the total volume of blood products transfused perioperatively, and its safety profile. Study participants were adult patients undergoing elective major aortic cardiovascular surgery at a tertiary referral hospital, who were equally randomized to receive a single dose of either FEIBA or matched placebo intraoperatively at the end of CPB. RESULTS Twenty patients were screened and 12 were randomized and included in the analysis. Protocol adherence was high, and all patients received the study drug per intention-to-treat except one patient. There were no protocol deviations or events of unblinding, and adverse events were not different between groups. Patients in the FEIBA group were older and more likely to be female and had higher BMI, lower hematocrit, and longer hypothermic circulatory arrest. There were no differences in post-randomization blood product transfusions (difference FEIBA vs. placebo -899 mL; 95% CI -5206 to 3409) or in the administration of open-label FEIBA. CONCLUSIONS This pilot trial confirmed the adequacy of the trial design that involved the early, blinded administration of FEIBA, by demonstrating excellent protocol adherence. We conclude that a larger trial establishing the effectiveness of early prothrombin complex concentrate administration to reduce the use of blood products in the setting of high-risk cardiac surgery is feasible. TRIAL REGISTRATION ClinicalTrials.gov, NCT02577614 . Registered 16 October 2015.

Abstract

Pathogen reduction (PR) technologies for blood components have been established to reduce the residual risk of known and emerging infectious agents. THERAFLEX UVPlatelets, a novel UVC light-based PR technology for platelet concentrates, works without photoactive substances. This randomized, controlled, double-blind, multicenter, noninferiority trial was designed to compare the efficacy and safety of UVC-treated platelets to that of untreated platelets in thrombocytopenic patients with hematologic-oncologic diseases. Primary objective was to determine non-inferiority of UVC-treated platelets, assessed by the 1-hour corrected count increment (CCI) in up to eight per-protocol platelet transfusion episodes. Analysis of the 171 eligible patients showed that the defined non-inferiority margin of 30% of UVC-treated platelets was narrowly missed as the mean differences in 1-hour CCI between standard platelets versus UVC-treated platelets for intention-to-treat and perprotocol analyses were 18.2% (95% confidence interval [CI]: 6.4%; 30.1) and 18.7% (95% CI: 6.3%; 31.1%), respectively. In comparison to the control, the UVC group had a 19.2% lower mean 24-hour CCI and was treated with an about 25% higher number of platelet units, but the average number of days to next platelet transfusion did not differ significantly between both treatment groups. The frequency of low-grade adverse events was slightly higher in the UVC group and the frequencies of refractoriness to platelet transfusion, platelet alloimmunization, severe bleeding events, and red blood cell transfusions were comparable between groups. Our study suggests that transfusion of pathogen-reduced platelets produced with the UVC technology is safe but non-inferiority was not demonstrated. (The German Clinical Trials Register number: DRKS00011156).