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Transfusion Related Complication clinical trials

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NCT ID: NCT03999229 Recruiting - Clinical trials for Transfusion Related Complication

S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion

Start date: July 25, 2019
Phase: Phase 1
Study type: Interventional

The Purpose of the study is to test the hypothesis that administration of an S-nitrosylating (SNO) agent can improve tissue oxygenation during transfusion of packed red blood cells (RBCs).

NCT ID: NCT03934112 Not yet recruiting - Clinical trials for Transfusion Related Complication

Impact of Transfusional Practice on the Morbidity and Mortality of Patients in Intensive Care Unit

PATMORE
Start date: June 2019
Phase:
Study type: Observational

This study will allow correlating transfusion monitoring and patients' prognostic according to the chosen outcome criteria. These data could thus represent a basis for transfusion recommendations, except for intensive care and vital emergencies. It will also bring information about the actual transfusion monitoring in intensive care unit (ICU), in the period following the stay in the ICU and after hospital discharge.

NCT ID: NCT03815773 Completed - Hemorrhage Clinical Trials

PRospective Multicenter Observational Study on Transfusion Practice in Vv-ECMO Patients: The PROTECMO Study

PROTECMO
Start date: December 1, 2018
Phase:
Study type: Observational

Background: Over the past decade, the use of extracorporeal membrane oxygenation (ECMO) for respiratory support in adults has increased. Several trials have highlighted how red blood cells transfusion can cause several negative effects and, currently, a restrictive transfusion trigger in critically ill patients is widely accepted. The optimal management of anticoagulation targets and transfusion practice in veno-venous-ECMO (VV-ECMO) patients is still under debate. Traditionally, the threshold for transfusions of packed red blood cells (PRBC) in ECMO is aimed at keeping hemoglobin (Hb) values in the normal range (12-14 g/dL), but some case series have shown how the Hb target can be lower, and with comparable clinical outcomes. While there are extensive reviews on predicted ECMO survival, and management (even with many debated issues), there is a significant knowledge gap in understanding the benefits and risks of transfusions during VV-ECMO Methods/Design: Prospective observational multicenter study. The principal aim is to describe current effective blood product usage, during VV-ECMO. The secondary aim is to describe in a large cohort of ECMO patients the current anticoagulation strategy and bleeding episodes occurrence. The study will be conducted at a multicenter level including in each center all consecutive adult vv-ECMO patients during one year up. The data collection will include pre-ECMO characteristics, transfusion strategies and blood test results during the first twenty-eight days after ECMO cannulation or until the end of ECMO support if the length is shorter, and clinical outcomes up to the end of ICU stay. The descriptive variable end points for the primary aim will be the daily and the total amount of PRBC and other blood products (Plasma, Platelets, Fibrinogen, Antithrombin III). The descriptive variable end points for the secondary aim will be the type and dose of anticoagulation, and episodes of bleeding according to site and severity. Expected Results: A collaborative combination of ECMO centers will evaluate prospective data of transfusion practices during ECMO. The investigators would be able to describe the currently strategy for administration of blood products, anticoagulation and the effective incidence of bleeding episodes worldwide.

NCT ID: NCT03784794 Completed - Clinical trials for Post Partum Hemorrhage

Patient Blood Management for Massive Obstetric Hemorrhage

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Obstetric Hemorrhage continues to be the first cause of maternal morbidity and mortality around the world especially in middle to low income countriesThe blood components are high value resources; however, its use has been shown to be a risk factor of known complications. The aim of the study is to compare two algorithms of coagulation management in massive obstetric hemorrhage Methods A randomized prospective trial single center two arms study in patients with severe obstetric hemorrhage (PPH > 1000) 2 different transfusion protocols one guided by thromboelastometry and hemostatic drugs (protrombine complex concentrate and fibrinogen concentrate) and the second guided by standard coagulation test and hemocomponents. Sample is calculated to known variance, Analyses are intention-to-treat without imputation, with outcomes will be performed between groups using mixed-effects two level regression models. For binary outcomes, a logistic model will be used and results presented as adjusted odds ratios (ORs) alongside 95% confidence intervals (CIs). Count data will be analysed using Poisson multilevel or negative binomial models. Primary Outcome Parameter: Compare between the two protocols: Number of allogeneic blood products transfused intra-op, within 24h after screening and in-hospital (RBC, Platelets and FFP; separate and overall) Secondary Outcome Parameter: Analysis of mortality, lenth of stay admission to the ICU, hysterectomy surgical reintervencion, Transfuse associated circulatory overload, Transfusion associated Acute lung injury, health associated infection will be measured as secondary outcome.

NCT ID: NCT03764813 Completed - Clinical trials for Transfusion Related Complication

Cord Blood Transfusion In Preterm Neonates (CB-TrIP)

CB-TrIP
Start date: December 5, 2018
Phase:
Study type: Observational

Repeated transfusions have been associated with very poor outcome of preterm infants. Fetal hemoglobin (HbF) and adult Hb (HbA) have different affinity for oxygen. The high level of adult Hb may contribute to exacerbating the oxidative damage responsible for prematurity diseases. The investigators hypothesized that transfusing red blood cells (RBC) obtained from allogeneic cord blood (CB) of healthy full-term babies (which contains almost exclusively HbF) may prevent the non-physiological decrease of HbF in premature neonates, likewise protecting them from oxygen radical diseases. Cord blood transfusion in preterms - CB TRIP - is a monocentric prospective nonrandomized study aimed to monitor HbF levels in preterm neonates receiving RBC transfusions from either umbilical blood of full-term healthy babies (CB-RBC) and/or from adult donors (A-RBC).

NCT ID: NCT03476005 Completed - Clinical trials for Transfusion Related Complication

Proficiency Based Training to Investigate WBIT

Start date: July 5, 2017
Phase: N/A
Study type: Interventional

Incorrect labelling of blood samples occurs at a rate of 1% in the general laboratories and 6% in Blood Transfusion Laboratories. The most serious error 'Wrong Blood in Tube' (WBIT) occurs when blood is taken from the intended patient, but labelled with another patient's details. Consequences may include, misinterpretation of a patient's diagnosis or clinical status, incorrect referral or treatment of a patient, or in the worst case scenario, incorrect cross matching for blood of the wrong blood group, which may lead to catastrophic outcomes, including death. The root causes for these errors is failure to identify the patient correctly and failure to correctly label the blood tubes at the bedside. To date, despite significant initiatives, it has proved very difficult to eradicate or reduce the error rate. Our project involves a novel, technology enhanced learning approach using proficiency based progression in a prospective randomised controlled methodology to significantly reduce this error. This approach to learning is more efficient and effective than the traditional approach of repeated practice and is made possible with metric-based simulations. This project will reduce the incidence of adverse events and avoidable medical errors associated with sampling and labelling errors including WBITs. This will be achieved by training healthcare practitioners to a proficiency standard in venepuncture. Thereby minimising the failure of health care professionals to identify the patient correctly and failure to correctly label the blood tubes at the bedside. This project's impact will deliver reduced sampling and labelling errors -including WBITs by a factor of 40-69%. Reductions of this magnitude will have profound national and international implications on how these types of skills are acquired and quality assured. This would result in improved patient safety and savings of over €500,000 at Cork University Hospital and if applied nationally result in exchequer savings of millions of euro annually.

NCT ID: NCT03394274 Completed - Clinical trials for Transfusion Related Complication

Restrictive Versus Liberal Transfusion, Major Surgeries

transfusion
Start date: June 14, 2017
Phase: N/A
Study type: Observational

Investigators aimed to compare the restrictive and liberal blood transfusion methods applied in major surgical operations performed in Anesthesiology and Reanimation Clinic and investigate their effects on postoperative transfusion needs, morbidity and mortality.

NCT ID: NCT03365999 Completed - Knee Osteoarthritis Clinical Trials

Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss and Transfusion After Total Knee Replacement.

Start date: October 15, 2017
Phase: Phase 2
Study type: Interventional

This study compares two oral medications (tranexamic acid and aminocaproic acid) as hemostatic agent administered in patients undergoing total knee replacement.

NCT ID: NCT02587845 Not yet recruiting - Bleeding Clinical Trials

Use of Transexamic Acid in Hip Replacement

Start date: October 2015
Phase: Phase 3
Study type: Interventional

Studies have shown that tranexamic acid reduces blood loss and transfusion need in patients undergoing total hip arthroplasty. However, no to date, no study has been large enough to determine definitively whether the drug is safe and effective. The present study was designed to verify noninferior efficacy and safety of topical intra-articular TXA compared with intravenous TXA in primary THA.

NCT ID: NCT02461264 Recruiting - Clinical trials for Transfusion Related Complication

Transfusion Strategy in Hematological Intensive Care Unit

1VERSUS2CGR
Start date: January 2016
Phase: Phase 3
Study type: Interventional

Patients with acute hematological disease (acute leukemia, aplastic anemia, hematopoietic stem cells autologous or allogeneic ...) and hospitalized in an intensive care unit hematology require compensation of anemia and thrombocytopenia by blood transfusions of red blood packed cells (RBP) or platelet concentrates (PC).The AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé) recommendations (2002) specify the need to transfuse 2 RBP in case of symptomatic anemia usually for a hemoglobin between 6 and 10 g / dL. These recommendations allow to transfuse a single RBP for very elderly patients or in cases of associated heart disease (heart failure). A recent development (2012) on post-transfusion pulmonary edema overload recommends transfusion unit by unit for high risk patients. More recently, a Swiss team has historically compared transfusion policies in 2 139 patients with hematological malignancies. The first group received 2 RBP transfusion in case of symptomatic anemia or hemoglobin level <6 g / dL. The other group only received 1 RBP at each transfusion. In total 2212 units in 1548 transfusions were performed and the 1 RBP transfusion policy has resulted in a 25% decrease in the number of RBP used without any complication. In a prospective single-center pilot study, we showed that transfusing a single RBP was possible without increasing the side effects of anemia, without complications and allow an overall reduction in consumption of red blood cell units. Several meta-analyzes reported in intensive care or bleeding situations that a restrictive use of transfusions significantly reduces cardiac events, bleeding, bacterial infections and mortality. The number of patient to be treated to prevent one death is 33. The main objective is to demonstrate in a randomized trial that the restrictive strategy (transfusion of a single unit at each transfusion) is not inferior to the liberal strategy (transfusion of 2 unit at each transfusion) in terms of severe complication. Transfusion are performed in case of hemoglobin level <8g/dL. Key secondary objectives are to reduce the number of RBP used and the cost of hospitalization with a comparison of complications/mortality in the 2 groups.