ABSTRACT
BACKGROUND: Anaemia is common in patients undergoing major surgery. The current standard of care for patients with low haemoglobin in the peri-operative period is blood transfusion. The presence of preoperative anaemia is associated with an increased likelihood of the patient receiving peri-operative transfusion and worsened outcomes following surgery, more post-operative complications, delayed recovery and greater length of hospital stay. Intravenous iron, if applied in the preoperative setting, may correct anaemia by the time of surgery and reduce the need for blood transfusion and improve outcomes. METHODS/DESIGN: PREVENTT is a phase III double-blind randomised controlled trial that will compare the use of intravenous ferric carboxymaltose (dose 1000 mg) with placebo 10-42 days before major open abdominal surgery in 500 patients with anaemia (haemoglobin < 120 g/L). The primary outcome measure will be the need for blood transfusion and secondary endpoints will include post-operative recovery, length of hospital stay, health care utilisation and cost analysis. TRIAL REGISTRATION: ISRCTN67322816--registered 9 October 2012. ClinicalTrials.gov identifier: NCT01692418.
Subject(s)
Abdomen/surgery , Anemia/drug therapy , Ferric Compounds/administration & dosage , Hematinics/administration & dosage , Maltose/analogs & derivatives , Administration, Intravenous , Anemia/blood , Anemia/diagnosis , Anemia/economics , Biomarkers/blood , Blood Transfusion , Clinical Protocols , Cost-Benefit Analysis , Double-Blind Method , Drug Costs , England , Ferric Compounds/adverse effects , Ferric Compounds/economics , Health Resources/economics , Health Resources/statistics & numerical data , Hematinics/adverse effects , Hematinics/economics , Hemoglobins/metabolism , Hospital Costs , Humans , Length of Stay , Maltose/administration & dosage , Maltose/adverse effects , Maltose/economics , Preoperative Care , Recovery of Function , Research Design , Time Factors , Treatment OutcomeSubject(s)
Anemia, Aplastic/diagnosis , Adult , Anemia, Aplastic/complications , Anemia, Aplastic/therapy , Blood Component Transfusion/methods , Bone Marrow Examination/methods , Bone Marrow Transplantation/methods , Diagnosis, Differential , Evidence-Based Medicine/methods , Female , Histocompatibility Testing , Humans , Immunosuppressive Agents/therapeutic use , Middle Aged , Opportunistic Infections/complications , Opportunistic Infections/prevention & control , Pregnancy , Pregnancy Complications, Hematologic/therapyABSTRACT
This prospective observational study reports on 126 women from 25 UK centres with image-proven antenatal venous thromboembolism (VTE), 62% deep vein thrombosis and 38% pulmonary embolism. Thrombophilia screening was of limited benefit except to identify antithrombin deficiency. Sixteen (13%) patients had previous VTE, all but one was related to previous pregnancy or combined oral contraceptive and 12 received no thromboprophylaxis in the index pregnancy, the other four thus received inadequate low molecular weight heparin (LMWH) doses. Treatment was with dalteparin in 25%, enoxaparin in 47%, tinzaparin in 25% and unfractionated heparin alone in 3%. 66% of patients received once-daily LMWH. Anti-activated factor X (anti-Xa) monitoring was performed at 90% of centres, with a wide range of target values. Thus current management of antenatal VTE, despite widely diverse clinical practice, appeared effective and safe, for there were no recurrent events and postpartum haemorrhage was not increased when compared to known rates. Larger studies are required to confirm this. The need for twice as opposed to once daily LMWH and for anti-Xa monitoring is questioned by this study. The importance of clinical risk assessment and adherence to the Royal College of Obstetricians and Gynaecologists guidelines on antenatal thromboprophylaxis, with adequate LMWH dosing is confirmed.
Subject(s)
Anticoagulants/therapeutic use , Heparin, Low-Molecular-Weight/therapeutic use , Pregnancy Complications, Cardiovascular/drug therapy , Venous Thromboembolism/drug therapy , Adolescent , Adult , Contraceptives, Oral, Combined/adverse effects , Female , Humans , Leg/blood supply , Length of Stay , Pedigree , Postpartum Hemorrhage/etiology , Pregnancy , Pregnancy Complications, Cardiovascular/pathology , Pregnancy Outcome , Pregnancy Trimesters , Prenatal Care , Prospective Studies , Recurrence , Risk Factors , Treatment Outcome , Venous Thromboembolism/pathologySubject(s)
Colony-Stimulating Factors/therapeutic use , Hematologic Neoplasms/therapy , Bone Marrow Transplantation , Graft vs Host Disease/prevention & control , Hematopoietic Stem Cell Mobilization , Humans , Leukemia/drug therapy , Lymphoma/drug therapy , Myelodysplastic Syndromes/drug therapy , Transplantation, AutologousABSTRACT
Autoimmune thrombocytopenia is generally caused by autoantibodies against glycoprotein (GP) IIb-IIIa or GPIb-IX and occasionally against GPIa-IIa or GPV. By investigating 38 rheumatoid arthritis (RA) patients on gold therapy, 10 with profound thrombocytopenia and 28 nonthrombocytopenic controls, we showed that in all 10 patients with thrombocytopenia, the platelet autoantibodies preferentially targeted GPV but the presence of gold was not required for their reactivity. Elevated levels of platelet-associated IgG (PAIgG) were observed in 8 of the 10 patients in whom the tests were performed. In 5 patients with sufficient autologous platelets, the GPV specificity of PAIgG was confirmed. Tests with GPV transfectants revealed that the antibodies reacted with GPV independent of GPIb alpha, GPIb beta, or GPIX. Autoantibodies recognizing GPV were not seen in the 28 nonthrombocytopenic control RA patients. Thus, GPV seems to be targeted in gold-induced autoimmune thrombocytopenia.
