Ferric carboxymaltose with or without erythropoietin in anemic patients with hip fracture: a randomized clinical trial.

BACKGROUND: The increasing incidence of osteoporotic hip fracture (HF) has raised the requirements of red blood cell (RBC) transfusions, whereas this scarce resource may cause morbidity and mortality. STUDY DESIGN AND METHODS: This study was a multicenter, randomized, double-blind, clinical trial that aimed to assess efficacy of ferric carboxymaltose (FCM) with or without erythropoietin (EPO) in reducing RBC transfusion in the perioperative period of HF. Participants (patients > 65 years admitted with HF and hemoglobin [Hb] levels of 90-120 g/L) were randomly assigned to receive a preoperative single dose of 1 g of FCM (short intravenous [IV] infusion over 15 min), plus 40,000 IU of subcutaneous EPO (EPOFE arm); versus 1 g of IV FCM plus subcutaneous placebo (FE arm); and versus IV and subcutaneous placebo (placebo arm). Primary endpoint was the percentage of patients who received RBC transfusion, and secondary endpoints were the number of RBC transfusions per patient, survival, hemoglobinemia, and health-related quality of life (HRQoL; by means of Short Form 36 Version 2 questionnaire). RESULTS: A total of 306 patients (85% women, mean age 83 ± 6.5 years) were included. A total of 52, 51.5, and 54% of patients required RBC transfusion in the EPOFE, FE, and placebo arms, respectively, with no significant differences in the number of RBC transfusions per patient, survival, HRQoL, and adverse events among treatment groups. A significant increase in Hb levels was achieved at discharge (102 g/L vs. 97 g/L) and 60 days after discharge (125 g/L vs. 119 g/L) in the EPOFE arm with respect to placebo arm; in addition, a higher rate of patients recovered from anemia in the EPOFE arm with respect to the placebo arm (52% vs. 39%), 60 days after discharge. CONCLUSION: Preoperative treatment with FCM alone or in combination with EPO improved recovery from postoperative anemia, but did not reduce the needs of RBC transfusion in patients with HF.

Active chest compression-decompression for cardiopulmonary resuscitation.

BACKGROUND: Active compression-decompression cardiopulmonary resuscitation (ACDR CPR) uses a hand-held suction device, applied mid-sternum, to compress the chest then actively decompress the chest after each compression. Randomised controlled trials testing this device have shown discordant results. OBJECTIVES: To determine the effect of active chest compression-decompression CPR compared to standard chest compression CPR on mortality and neurological function in adults with cardiac arrest treated either in-hospital or out-of-hospital. SEARCH METHODS: We updated the searches of CENTRAL in The Cochrane Library (Issue 12 of 12, 2012), MEDLINE (OVID, 1946 to January week 1 2013), and EMBASE (OVID, 1980 to week 1 2013) on 14 January 2013. We checked the reference list of retrieved articles, contacted experts in the field, and searched ClinicalTrials.gov. SELECTION CRITERIA: All randomised or quasi-randomised studies comparing active compression-decompression with standard manual chest compression in adults with a cardiac arrest who received cardiopulmonary resuscitation by a trained medical or paramedical team. DATA COLLECTION AND ANALYSIS: We independently extracted data on an intention-to-treat basis. When needed, we contacted the authors of the primary studies. If appropriate, we cumulated studies and pooled relative risk (RR) estimates. We predefined subgroup analyses according to setting (out-of-hospital or in-hospital) and attending team composition (with physician or paramedic only). MAIN RESULTS: In this update, 27 new related publications were found, but they did not all fulfil inclusion criteria or concerned participants already reported in previous publications. In the end, we included 10 trials in this review: Eight were in out-of-hospital settings; one was set in-hospital only; and one had both in-hospital and out-of-hospital components. Allocation concealment was adequate in four studies. The two in-hospital studies were different in quality and size (773 and 53 participants). Both found no differences between ACDR CPR and STR in any outcome.Out-of-hospital trials cumulated 4162 participants. There were no differences between ACDR CPR and STR for mortality either immediately (RR 0.98, 95% confidence interval (CI) 0.94 to 1.03) or at hospital discharge (RR 0.99, 95% CI 0.98 to 1.01). The pooled RR of neurological impairment of any severity was 1.71 (95% CI 0.90 to 3.25), with a non-significant trend to more frequent severe neurological damage in survivors of ACDR CPR (RR 3.11, 95% CI 0.98 to 9.83). However, assessment of neurological outcome was limited, and few participants had neurological damage.There was no difference between ACDR CPR and STR with regard to complications such as rib or sternal fractures, pneumothorax, or haemothorax (RR 1.09, 95% CI 0.86 to 1.38). Skin trauma and ecchymosis were more frequent with ACDR CPR. AUTHORS' CONCLUSIONS: Active chest compression-decompression in people with cardiac arrest is not associated with any clear benefit.

Ferric carboxymaltose with or without erythropoietin for the prevention of red-cell transfusions in the perioperative period of osteoporotic hip fractures: a randomized contolled trial. The PAHFRAC-01 project.

BACKGROUND: Around one third to one half of patients with hip fractures require red-cell pack transfusion. The increasing incidence of hip fracture has also raised the need for this scarce resource. Additionally, red-cell pack transfusions are not without complications which may involve excessive morbidity and mortality. This makes it necessary to develop blood-saving strategies. Our objective was to assess safety, efficacy, and cost-effictveness of combined treatment of i.v. ferric carboxymaltose and erythropoietin (EPOFE arm) versus i.v. ferric carboxymaltose (FE arm) versus a placebo (PLACEBO arm) in reducing the percentage of patients who receive blood transfusions, as well as mortality in the perioperative period of hip fracture intervention. METHODS/DESIGN: Multicentric, phase III, randomized, controlled, double blinded, parallel groups clinical trial. Patients > 65 years admitted to hospital with a hip fracture will be eligible to participate. Patients will be treated with either a single dosage of i.v. ferric carboxymaltose of 1 g and subcutaneous erythropoietin (40.000 IU), or i.v. ferric carboxymaltose and subcutaneous placebo, or i.v. placebo and subcutaneous placebo. Follow-up will be performed until 60 days after discharge, assessing transfusion needs, morbidity, mortality, safety, costs, and health-related quality of life. Intention to treat, as well as per protocol, and incremental cost-effectiveness analysis will be performed. The number of recruited patients per arm is set at 102, a total of 306 patients. DISCUSSION: We think that this trial will contribute to the knowledge about the safety and efficacy of ferric carboxymaltose with/without erythropoietin in preventing red-cell pack transfusions in patients with hip fracture. CLINICALTRIALS.GOV IDENTIFIER: NCT01154491.