All data were collected prospectively in-line with clinical routine and were recorded in a structured database. Regular visits were scheduled until 24 months. At the first visit of the CCP, structured history was taken as well as physical examination. Clinical risk factors were assessed. Laboratory tests were performed 1 months after stop anticoagulant treatment (e.g., D-dimer, factor VIII). Clinical outcomes were assessed until the last visit. Patients were additionally followed over the course of further outpatient visits and accessing MUMC and general practitioner records. Observer were not aware about outcomes while assessing predictors and predictors while assessing outcomes, respectively. Laboratory tests were conducted at pre-specified time points as previously described (35 (link)). A protocol was implemented to ensure adequate pre-analytical conditions (15 (link)). D-dimer levels were determined using the Vidas assay (bioMérieux Clinical Diagnostics, Marcy-l'Etoile, France) or Innovance, respectively (Siemens Healthcare, Marburg, Germany). Factor VIII was analyzed using a one-stage assay (Actin FS, Siemens Healthcare, Marburg, Germany) on a Sysmex CA7000 (distributed by Siemens Healthcare, Marburg, Germany).
Vidas assay
Manufactured by bioMérieux
Sourced in France
The Vidas assay is a compact, automated immunoassay system developed by bioMérieux. It is designed to perform a variety of diagnostic tests, including the detection and quantification of analytes in biological samples. The Vidas assay utilizes a specific immunological reaction between the target analyte and a corresponding antibody, enabling rapid and reliable analysis.
Automatically generated - may contain errors
4 protocols using vidas assay
1
Prospective Clinical Cohort Protocol
2
Standardized Procedures for Biomarker Analysis
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Laboratory data were determined in a certified MUMC+ laboratory using established methods as previously described.28 Venous blood samples were collected in commercially available tubes with and without citrate 0.106 mol/l as appropriate following an established protocol to ensure adequate preanalytic conditions. Samples were centrifuged according to recent guidelines (10 minutes at 1500 g or 5 minutes at 2500 g, respectively). D‐dimer and CRP was measured after centrifugation. Plasma for factor VIII measurements were snap‐frozen at −80°C. D‐dimer were determined using the Vidas assay until May 2008 (bioMérieux Clinical Diagnostics, Marcy‐l'Etoile, France) and the Innovance assay from June 2008 (Siemens Healthcare, Marburg, Germany). Factor VIII was determined using a one‐stage coagulometric assay (Actin FS; Siemens Healthcare, Marburg, Germany). Both assays were run on a Sysmex CA7000 (Siemens, Marburg, Germany). CRP was determined with a turbidimetric test (Synchron LX Systems, Beckman Coulter Inc., Fullerton, CA, USA).
3
Plasma D-dimer and Serum CEA Levels in Surgical Oncology
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In order to measure the plasma D-dimer and serum CEA levels, peripheral blood samples were collected after an overnight fasting three days before the operation day. DD was analyzed using the VIDAS® assay (Biomerieux®, USA). VIDAS D-Dimer Exclusion™ II is an automated test for the immunoenzymatic determination of fibrin degradation products in human plasma.
CEA was measured using an electrochemiluminescence immunoassay with the Architect CEA® immunoassay analyzer (Abbott Laboratories).
The relationship between the demographic features, tumor size, localization, pathologic stage, and the preoperative plasma D-dimer and serum CEA levels of the patients was evaluated. In addition, the survival rate during the postoperative follow-up and the factors affecting the survival were examined.
CEA was measured using an electrochemiluminescence immunoassay with the Architect CEA® immunoassay analyzer (Abbott Laboratories).
The relationship between the demographic features, tumor size, localization, pathologic stage, and the preoperative plasma D-dimer and serum CEA levels of the patients was evaluated. In addition, the survival rate during the postoperative follow-up and the factors affecting the survival were examined.
4
Procalcitonin-Guided Antibiotic Therapy
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The first 24 hours from the start of antibiotics, patients were 1:1 randomized into the PCT-guidance arm or the SOC arm by a generated list per site kept in a sealed envelope until randomization. Patients and investigators were aware of treatment assignment.
Attending physicians prescribed antimicrobials according to European and national guidelines (17 ). Blood samples were collected at baseline and on Day 5 for procalcitonin measurements using the VIDAS assay (lower detection limit 0.05 μg/L; bioMérieux). Antibiotics were discontinued if PCT was reduced by at least 80% or if it was <0.5 μg/L. When the rule did not apply, blood sampling was repeated daily and antibiotics were discontinued when the rule was met. Exceptions were allowed for medically unstable patients defined as febrile and/or requiring vasopressors. For patients in the SOC arm, the investigators were unaware of PCT kinetics and the duration of antimicrobial treatment was decided according to international guidelines (18 (link)).
Stool samples of 0.5 g were collected at baseline and on follow-up Days 7, 28, and 180 to detect C. difficile and MDRO colonization (see online supplement).
Attending physicians prescribed antimicrobials according to European and national guidelines (17 ). Blood samples were collected at baseline and on Day 5 for procalcitonin measurements using the VIDAS assay (lower detection limit 0.05 μg/L; bioMérieux). Antibiotics were discontinued if PCT was reduced by at least 80% or if it was <0.5 μg/L. When the rule did not apply, blood sampling was repeated daily and antibiotics were discontinued when the rule was met. Exceptions were allowed for medically unstable patients defined as febrile and/or requiring vasopressors. For patients in the SOC arm, the investigators were unaware of PCT kinetics and the duration of antimicrobial treatment was decided according to international guidelines (18 (link)).
Stool samples of 0.5 g were collected at baseline and on follow-up Days 7, 28, and 180 to detect C. difficile and MDRO colonization (see online supplement).
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