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Transfusion-dependent Anemia clinical trials

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NCT ID: NCT05466370 Completed - Clinical trials for Transfusion-dependent Anemia

Prediction of Transfusion-Associated Complications

PRETRACO
Start date: July 15, 2022
Phase:
Study type: Observational

Currently, about 350000 red blood cell concentrates are produced from blood donations in Austria every year. In addition to the main effect of replacing lost blood, red blood cell concentrates also have many undesirable effects - from blood group compatibilities, which are easily avoidable due to care, to storage-related side effects, to mostly intensive care problems as a result of massive transfusions, to system-wide effects such as TRALI, TACO and TRIM. Before being administered to patients, red blood cell concentrates undergo an extensive quality assurance process in which a large number of parameters are collected. Prior to use on patients, for example, bedside tests and tests for further incompatibilities with a blood sample from the intended patient are performed. With the implementation of Patient Blood Management (PBM) in recent years, the use of red cell concentrates has become more targeted - the number of transfusions is decreasing in most developed countries. However, it is still possible to suffer transfusion-related adverse events (TRAE). Thus, active research activity to reduce these TRAEs continues to be called for. To date, however, it is not known which patients experience transfusion-related adverse events. Despite the broad measures of hemovigilance and pre-transfusion testing, it is still not possible to predict which individual patient will respond to a transfusion with a typical adverse event such as hypotension, hemolysis, renal failure, or TRALI. It seems understandable that characteristics of the patient as well as characteristics of the administered unit could play a role for this. In particular, it is conceivable that a combination of characteristics of the blood unit and characteristics of the patient could determine a complication in the course of administration. For this reason, it seems attractive to use artificial intelligence and machine learning methods to predict any complications.

NCT ID: NCT05203016 Completed - Hypothermia Clinical Trials

Complications Associated With Intraoperative Hypothermia.

Start date: January 1, 2019
Phase:
Study type: Observational

Maintaining intraoperative normothermia and temperature measurement is a marker of quality of care. We know that intraoperative hypothermia is associated with an increased risk of cardiovascular events, infection of the surgical wound, a longer hospital stay, discomfort, hemorrhage and transfusion demand. Goals: To know the incidence of perioperative hypothermia in routine clinical practice in different surgical settings in a national reference university hospital. To establish if hypothermia is a risk factor for developing postoperative complications, focusing mainly on bleeding and infection of the surgical wound, in subjects aged between 18-65 years who come to the La Paz University Hospital for a surgical intervention in the Obstetrics / Plastic and Maxillofacial Surgery Services. Hospital-based cohort study. A two-year follow-up of patients between 18 and 65 years will be carried out. Those patients with haemostasis disorders and infections in the preoperative period will be excluded. Using a questionnaire on sociodemographic variables, the baseline conditions of the patients will be evaluated for inclusion in the study. Subsequently, the temperature will be measured at the beginning and at the end of the surgery, as well as during admission to the Post Anesthesia Care Unit, where the temperature normalization time will be noted in the event of hypothermia. In retrospect, those variables corresponding to the late postoperative period will be evaluated and the telephone interview will be conducted to assess the quality of care received. All the data will be reflected in the collection booklet that we present in the annex. Patient demographics, case characteristics, and temperature records were summarized using descriptive statistics. Microsoft Excel (Professional Plus 2010, version 14); it was used for data management and processing, with Stata (version 14; StataCorp LP, College Station, TX) for graphical representations and statistical tests. A multivariate analysis of potential confounding factors will be performed. These results will serve to know the incidence of hypothermia according to the usual practice in a Spanish tertiary hospital and to establish recommendations in the management of intraoperative hypothermia and its prevention.

NCT ID: NCT04856618 Completed - Clinical trials for Transfusion-dependent Anemia

Machine Learning-Based Prediction of Major Perioperative Allogeneic Blood Requirements in Cardiac Surgery

PREMATRICS
Start date: June 16, 2021
Phase:
Study type: Observational

Cardiac surgery is one of the clinical surgical specialties that carries a particularly high risk for patients to suffer from severe bleeding perioperatively and consequent anemia, which subsequently requires transfusion of allogeneic blood. Although a surprisingly high number of patients in cardiac surgery do not require perioperative transfusions, it is primarily those patients who do require transfusion who are subsequently at risk for a worse outcome. In recent years many studies have been published discussing measures that can assist physicians in avoiding the triad of anemia, bleeding, and transfusion in cardiac surgery. Within these publications, the implementation of Patient Blood Management (PBM) is advised. PBM is a set of measures aimed at improving patient outcome by reducing perioperative bleeding and thus preventing both anemia and bleeding. The three pillars of this bundle are the preoperative preparation of anemic patients with iron, erythropoietin, folic acid and vitamin B12, the prevention of intraoperative blood loss and the reasonable indication for allogeneic transfusions. Nevertheless, it must be mentioned that the implementation of at least part of these measures is laborious, and full implementation of the recommended bundle is therefore rarely achieved. As a consequence, the full potential of Patient Blood Management is not always realized. Unfortunately this means that transfusion of allogeneic blood cannot be prevented in many patients. A small proportion of patients undergoing cardiac surgery requires a very large amount of allogeneic blood perioperatively. These patients are typically those with a particularly poor outcome. Massive transfusion of allogeneic blood in this situation is an indicator of complications and a cause of increased mortality. Although cardiac surgeons and anesthesiologists believe they can assess which patients are at high risk for hemorrhage, recent publications indicate that there is an urgent need for adequate predictive methods. A variety of studies exist that attempt to predict perioperative transfusion requirements, but to date have been plagued by several limitations. Either the previous publications do not focus on the prediction of massive transfusion of allogeneic blood, i.e. administration of ten or more packed red blood cell units perioperatively, but on much lower transfusion volumes, have only low predictive strength to predict massive transfusion in daily clinical practice, or are hardly usable for true prediction because they use factors (features) that are not strictly present only in the preoperative phase. If an accurate prediction model based on a few features could be created and those patients particularly at risk of massive transfusion of allogeneic blood could be identified, it would subsequently be possible to develop an adapted clinical pathway that would allow patient care to be improved and individualized interventions adapted to the situation to be implemented. In the best case, an adapted care of patients would be possible, which is able to increase the acceptance for the use of even complex measures of patient blood management. This is especially true for measures such as preoperative preparation with iron and/or erythropoietin, the use of a cell saver, and a particularly careful surgical approach. Even if it is difficult to apply all measures of patient blood management in all patients, it would be possible with an approach as described to identify those patients who would benefit most from individualized approaches.

NCT ID: NCT04303910 Completed - Clinical trials for Transfusion-dependent Anemia

An Analysis of Blood Management in Patients Having Hip or Knee Arthroplasty

Start date: May 1, 2020
Phase:
Study type: Observational

The main objective of this study is to examine the transfusion rate and appropriateness in patients undergoing elective knee and hip replacement surgery at Siriraj Hospital

NCT ID: NCT04155021 Completed - Clinical trials for Transfusion-dependent Anemia

Knowledge and Attitude in Perioperative Erythrocyte Transfusion in Medical Personnel in Siriraj Hospital

Start date: January 15, 2020
Phase:
Study type: Observational

This study is designed to explore the correlation between knowledge and attitude in perioperative erythrocyte transfusion in medical personnel.

NCT ID: NCT02435212 Completed - Clinical trials for Transfusion-dependent Anemia

Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload

Start date: October 21, 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label, multicenter, two arm, phase II study to evaluate treatment compliance and change in serum ferritin of a deferasirox granule formulation and a deferasirox DT formulation in children and adolescents aged ≥ 2 and < 18 years at enrollment with any transfusion-dependent anemia requiring chelation therapy due to iron overload, to demonstrate the effect of improved compliance on iron burden. Randomization will be stratified by age groups (2 to <10 years, 10 to <18 years) and prior iron chelation therapy (Yes/ No). There will be two study phases which include a 1 year core phase where patients will be randomized to a 48 week treatment period to either Deferasirox DT or granules, and an optional extension phase where all patients will receive the granules up to 5 years. Patients who demonstrated benefit to granules or DT in the core phase, and/or express the wish to continue in the optional extension phase on granules, will be offered this possibility until there is local access to the new formulation (granules or FCT) or up to 5 years, whichever occurs first.