RESUMEN
BACKGROUND: Long patient transport times to trauma centers are a well-known problem in sparsely populated regions with a low hospital density. Transfusion of red blood cell concentrates (RBC) and plasma improves outcome of trauma patients with severe bleeding. Helicopter emergency services (HEMS) are frequently employed to provide early advanced medical care and to reduce time to hospital admission. Supplying HEMS with blood products allows prehospital transfusion and may help to prevent exsanguination or prolonged hemorrhagic shock. We have investigated the maintenance of blood product quality under air transport conditions and the logistical steps to introduce a HEMS blood depot into routine practice. METHODS: A risk analysis was performed and a validation plan developed. A special, commercially available transport container for blood products was identified. Maintenance of temperature conditions between 2 and 6°C in the box were monitored at ambient temperatures up to 35°C over 48 h. Quality of blood products before and after helicopter air transport were evaluated including (1) for RBCs: hemoglobin, hematocrit, hemolysis rate; (2) for thawed plasma: aPTT, INR, single clotting factor activities. The logistics for blood supply of the regional HEMS were developed by the transfusion service of the Greifswald University Hospital in collaboration with the in-hospital transport team, the HEMS team, and the HEMS operator. RESULTS: The transport container maintained a temperature below 6°C up to 36 h at 35°C ambient temperature. Vibration during helicopter operation did not impair quality of RBC and thawed plasma. To provide blood products for HEMS at least two transport containers and an additional set of cooling tiles is needed as the cooling tiles need a special temperature priming over 20 h. The two boxes were used at alternate days. To reduce wastage, RBCs and thawed plasmas were exchanged every fourth day and reintegrated into the blood bank inventory for further in-hospital use. CONCLUSIONS: Supplying HEMS with RBCs and plasma is feasible. Helicopter transport has no negative impact on blood product quality. The logistic challenges require close collaboration between the HEMS team and the blood transfusion service.
RESUMEN
BACKGROUND: Perioperative anaemia leads to impaired oxygen supply with a risk of vital organ ischaemia. In healthy and fit individuals, anaemia can be compensated by several mechanisms. Elderly patients, however, have less compensatory mechanisms because of multiple co-morbidities and age-related decline of functional reserves. The purpose of the study is to evaluate whether elderly surgical patients may benefit from a liberal red blood cell (RBC) transfusion strategy compared to a restrictive transfusion strategy. METHODS: The LIBERAL Trial is a prospective, randomized, multicentre, controlled clinical phase IV trial randomising 2470 elderly (≥ 70 years) patients undergoing intermediate- or high-risk non-cardiac surgery. Registered patients will be randomised only if Haemoglobin (Hb) reaches ≤9 g/dl during surgery or within 3 days after surgery either to the LIBERAL group (transfusion of a single RBC unit when Hb ≤ 9 g/dl with a target range for the post-transfusion Hb level of 9-10.5 g/dl) or the RESTRICTIVE group (transfusion of a single RBC unit when Hb ≤ 7.5 g/dl with a target range for the post-transfusion Hb level of 7.5-9 g/dl). The intervention per patient will be followed until hospital discharge or up to 30 days after surgery, whichever occurs first. The primary efficacy outcome is defined as a composite of all-cause mortality, acute myocardial infarction, acute ischaemic stroke, acute kidney injury (stage III), acute mesenteric ischaemia and acute peripheral vascular ischaemia within 90 days after surgery. Infections requiring iv antibiotics with re-hospitalisation are assessed as important secondary endpoint. The primary endpoint will be analysed by logistic regression adjusting for age, cancer surgery (y/n), type of surgery (intermediate- or high-risk), and incorporating centres as random effect. DISCUSSION: The LIBERAL-Trial will evaluate whether a liberal transfusion strategy reduces the occurrence of major adverse events after non-cardiac surgery in the geriatric population compared to a restrictive strategy within 90 days after surgery. TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03369210 ).
Asunto(s)
Anemia/terapia , Transfusión de Eritrocitos/métodos , Isquemia/prevención & control , Atención Perioperativa/métodos , Procedimientos Quirúrgicos Operativos , Factores de Edad , Anciano , Anciano de 80 o más Años , Anemia/sangre , Anemia/complicaciones , Anemia/mortalidad , Biomarcadores/sangre , Causas de Muerte , Ensayos Clínicos Fase IV como Asunto , Transfusión de Eritrocitos/efectos adversos , Transfusión de Eritrocitos/mortalidad , Femenino , Alemania , Hemoglobinas/metabolismo , Humanos , Isquemia/sangre , Isquemia/diagnóstico , Isquemia/etiología , Masculino , Estudios Multicéntricos como Asunto , Readmisión del Paciente , Atención Perioperativa/efectos adversos , Atención Perioperativa/mortalidad , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Procedimientos Quirúrgicos Operativos/efectos adversos , Procedimientos Quirúrgicos Operativos/mortalidad , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Emergency patients with unknown blood type usually receive O Rhesus D negative (RhD-) red blood cell concentrates until their blood group is determined to prevent RhD+ related adverse transfusion reactions. As 85% of individuals are RhD+, this consumption of O RhD- red blood cell concentrates contributes to shortages of O RhD- red blood cell concentrates, sometimes forcing transfusion of known RhD- patients with RhD+ red blood cell concentrates. Here we report the outcome of this transfusion policy transfusing all emergency patients with unknown blood type with O RhD+ red blood cell concentrates. METHODS: In this prospective single-centre observational study done between Jan 1, 2001, and Dec 31, 2015, we assessed all consecutive RhD- patients at the University Medicine Greifswald who received RhD+ red blood cell concentrates (emergency patients with unknown blood type; and RhD- patients receiving RhD+ red blood cell concentrates during RhD- red blood cell concentrate shortages). No patients were excluded. The primary endpoint was anti-D allo-immunisation at 2 months follow-up or later. Patients were followed up and tested for immunisation against red blood cell antigens using the direct antiglobulin test and an antibody screen every 3-5 days for 4 weeks or until death, or hospital discharge. Surviving patients were screened for development of anti-D antibodies for up to 12 months (at the predefined timepoints 2, 3, 6, and 12 months) after RhD+ red blood cell transfusion. FINDINGS: 437 emergency patients, of whom 85 (20%) were RhD-, received 2836 RhD+ red blood cell concentrates. The overall risk of inducing anti-D antibodies (in all 437 recipients) was 17 (4%, 95% CI 2·44-6·14) of 437 (assuming all patients lost to follow-up developed anti-D allo-immunisation). During this period, 110 known RhD- patients received RhD+ red blood cell concentrates during RhD- red blood cell concentrate shortages. Of these, 29 (26%; 95% CI 19·0-35·3) developed anti-D allo-immunisation (assuming all patients lost to follow-up developed anti-D), which was significantly higher than in the emergency patients with unknown blood type (p<0·0001). INTERPRETATION: Transfusing emergency patients with unknown blood type with O RhD+ red blood cell concentrates has a low risk of inducing anti-D antibodies (3-6%), but saves more than 10% of the total O RhD- red blood cell concentrate demand, thereby reducing shortage of O RhD- red blood cell concentrates, the need to transfuse known RhD-patients with RhD+ red blood cell concentrates, and thus the overall risk to induce anti-D allo-immunisation in the population. These findings should be considered for transfusion guidelines. FUNDING: University Medicine Greifswald.