Prevention of postoperative bleeding in hip fractures treated with prosthetic replacement: efficacy and safety of fibrin sealant and tranexamic acid. A randomised controlled clinical trial (TRANEXFER study).

INTRODUCTION: We assessed the efficacy of fibrin sealant (FS) and tranexamic acid (TXA) administered topically in patients with a hip fracture treated with prosthetic replacement. MATERIALS AND METHODS: Parallel, multicentre, open label, randomised, clinical trial. We compared three interventions to reduce blood loss: (1) 10 ml of FS, (2) 1 g of topical TXA, both administered at the end of the surgery, and (3) usual haemostasis (control group). The main outcome was blood loss collected in drains. Other secondary variables were total blood loss, hidden blood loss, transfusion rate, average hospital stay, complications, adverse events, and mortality. RESULTS: A total of 158 patients were included, 56 in the FS group, 52 in the TXA group, and 50 in the control group. The total amount of blood collected in drains was lower in the TXA group (148.6 ml, SD 122.7 in TXA; 168.2 ml, SD 137.4 in FS; and 201.5 ml, SD 166.5 in control group) without achieving statistical significance (p = 0.178). The transfusion rate was lower in the TXA group (32.7%), compared with FS group (42.9%) and control group (44.0%), without statistical significance (p = 0.341). There were no complications or adverse effects related to the evaluated interventions. CONCLUSIONS: The use of TXA and FS administered topically prior to surgical closure in patients with a sub-capital femoral fracture undergoing arthroplasty did not significantly reduce either postoperative blood loss or transfusion rate, compared with a group that only received usual haemostasis.

Transfusion strategies for acute upper gastrointestinal bleeding.

BACKGROUND: The hemoglobin threshold for transfusion of red cells in patients with acute gastrointestinal bleeding is controversial. We compared the efficacy and safety of a restrictive transfusion strategy with those of a liberal transfusion strategy. METHODS: We enrolled 921 patients with severe acute upper gastrointestinal bleeding and randomly assigned 461 of them to a restrictive strategy (transfusion when the hemoglobin level fell below 7 g per deciliter) and 460 to a liberal strategy (transfusion when the hemoglobin fell below 9 g per deciliter). Randomization was stratified according to the presence or absence of liver cirrhosis. RESULTS: A total of 225 patients assigned to the restrictive strategy (51%), as compared with 61 assigned to the liberal strategy (14%), did not receive transfusions (P<0.001) [corrected].The probability of survival at 6 weeks was higher in the restrictive-strategy group than in the liberal-strategy group (95% vs. 91%; hazard ratio for death with restrictive strategy, 0.55; 95% confidence interval [CI], 0.33 to 0.92; P=0.02). Further bleeding occurred in 10% of the patients in the restrictive-strategy group as compared with 16% of the patients in the liberal-strategy group (P=0.01), and adverse events occurred in 40% as compared with 48% (P=0.02). The probability of survival was slightly higher with the restrictive strategy than with the liberal strategy in the subgroup of patients who had bleeding associated with a peptic ulcer (hazard ratio, 0.70; 95% CI, 0.26 to 1.25) and was significantly higher in the subgroup of patients with cirrhosis and Child-Pugh class A or B disease (hazard ratio, 0.30; 95% CI, 0.11 to 0.85), but not in those with cirrhosis and Child-Pugh class C disease (hazard ratio, 1.04; 95% CI, 0.45 to 2.37). Within the first 5 days, the portal-pressure gradient increased significantly in patients assigned to the liberal strategy (P=0.03) but not in those assigned to the restrictive strategy. CONCLUSIONS: As compared with a liberal transfusion strategy, a restrictive strategy significantly improved outcomes in patients with acute upper gastrointestinal bleeding. (Funded by Fundació Investigació Sant Pau; ClinicalTrials.gov number, NCT00414713.).

Impact of pregnancy on women's health-related lifestyle habits: Diet, physical activity, alcohol consumption, and smoking.

OBJECTIVES: To explore health-related lifestyles in women before and during pregnancy, and to determine the potential differences between both and the relevant factors. MATERIALS AND METHODS: A cross-sectional observational study including 348 women with a child <5 years of age was conducted in six health areas. The following variables were recorded: sociodemographic (age, educational level, marital status, social class, type of cohabitation, nationality), health-related habits (physical activity, diet, tobacco use, alcohol consumption), health conditions, and medication intake. RESULTS: Four lifestyle habits were compared between the pre-conception and pregnancy periods: diet, physical activity, and alcohol and tobacco use. The proportion of women who consumed alcohol (42.8 % vs 3.4 %) or smoked (19.3 % vs 12.4 %) was significantly higher before conception (p < 0.01). Conversely, the proportion of inactive women was lower before pregnancy, with 23.3 % (CI95%: 18.7-27.9) formerly classified as active versus 35.3 % (CI95%: 30.2-40.5) (p < 0.01). Similarly, adherence to the Mediterranean diet increased during pregnancy (62.9 % vs 75.0 %; p < 0.01). Furthermore, 53.2 % (CI95%: 47.8-58.5) of women reported a change from non-healthy to healthy in at least one of the evaluated habits. Logistic regression analyses revealed the variables associated with a positive change, which were being national Spanish (OR: 6.9) and experiencing the first pregnancy (OR: 1.8). CONCLUSIONS: The lifestyles of women undergo changes between the pre-gestation and pregnancy periods. However, such variations do not affect all health-related habits similarly. A positive change was observed in diet, alcohol consumption, and smoking habit, whereas pregnancy negatively impacted on physical activity and sedentary behaviours.

Influence of the mother's lifestyles on the initiation of breastfeeding: A case-control study.

INTRODUCTION: Breast milk is the optimal food during the first months of life. The main objective was to analyse the factors associated with not initiating breastfeeding in terms of maternal lifestyles, epidemiological characteristics and information on breastfeeding. MATERIAL AND METHOD: Observational analytical study of cases and controls in 6 primary care centres. The sample included women with a child under 5 years, with an estimated necessary sample size of 166 cases (women who did not initiate breastfeeding) and 166 controls (women who began breastfeeding). Sociodemographic and maternal lifestyle variables were measured before and during pregnancy, such as physical activity using the BPAAT questionnaire, diet with the MEDAS-14 questionnaire, and tobacco and alcohol consumption. We assessed the information and opinions about breastfeeding as well as previous experience with it. RESULTS: The study included 348 women (174 cases and 174 controls) with a mean age of 33.4 years (SD, 5.4). The variables independently associated with not initiating breastfeeding were: absence of previous experience with breastfeeding (odds ratio [OR], 12.75), making the decision during pregnancy or delivery (OR, 10.55), not being married or in a partnership (OR, 3.42) and being sedentary for periods of 2 hours or greater/day during pregnancy (OR, 1.77). CONCLUSIONS: In our study, the determining factors associated with not initiating breastfeeding were the lack of previous experience with breastfeeding, the timing of the decision about breastfeeding, and marital status. When it came to lifestyle, only a sedentary lifestyle was associated with not initiating breastfeeding, while dietary or other habits had no influence.

Efficacy of autologous platelet-rich plasma for the treatment of muscle rupture with haematoma: a multicentre, randomised, double-blind, placebo-controlled clinical trial.

BACKGROUND: The goals of the treatment of muscle injuries are to shorten the time of healing and to avoid relapses. The aim of this study was to assess the efficacy of autologous platelet-rich plasma (PRP) in the healing of muscle injuries. MATERIALS AND METHODS: A multicentre, randomised, double-blind, parallel, controlled clinical trial was conducted in 71 patients (81.8% males) aged 45.6 (SD=10.0) years with muscle tears in the legs and haematoma. The haematoma was evacuated in all patients. Thirty-three patients were randomised to a single dose of autologous PRP and 38 patients to simulation of PRP administration. The primary end-point was time to complete recovery of muscle injury. Secondary end-points were pain, relapses, ultrasound parameters, and adverse events. The total follow-up per patient was 12 months. RESULTS: Time to complete recovery after the treatment was 31.63 days (SD=15.38) in the PRP group, and 38.43 days (SD=18.58) in the control group (p=0.261). Pain decreased over time in both groups without statistical differences between them. Eight patients relapsed (seven in the control group, and one in the PRP group). There were no adverse effects related to the interventions. DISCUSSION: Autologous PRP did not significantly improve the time to healing compared to that in the control group.