Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery
NCT ID: NCT03902275
Last Updated: 2020-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
20 participants
INTERVENTIONAL
2019-07-01
2020-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Conventional Versus Point-of-care Based Coagulation Management
NCT00997841
ROTEM-guided Transfusion Protocol in Attempt to Reduce Blood Transfusions in Major Oncological Surgery
NCT03993977
Blood Transfusion and Postoperative Outcome Before and After Implementing a Coagulation Management Algorithm
NCT03482128
Biological and Clinical Relevance of Quantra Viscoelastic Hemostatic Assay in Hemorrhagic Cardiac Surgery
NCT07105904
Perioperative Coagulation Management in Cardiac Surgery.
NCT00772239
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In recent years, point of care testing (POCT) devices for the diagnosis of coagulopathic patients have become increasingly important. In our clinic, POCT devices have been routinely used for intra- and postoperative targeted coagulation therapy for years. These include the ROTEM delta and Multiplate. For analysis, a whole blood sample is pipetted together with test reagents. Depending on the selected reagent, different parts of the coagulation cascade can be evaluated and, depending on this, an appropriate therapy can be derived. A coagulation algorithm developed in our clinic is based on these measurement results and has been used successfully for years for perioperative coagulation management. This algorithm requires additional information on the platelet function, which is also carried out as standard on the bed side using multi-plate analysis as POCT.
A new system for whole blood analysis has recently become available on the market. The Quantra from HemoSonics also allows the analysis of a whole blood sample on the bed side. Due to the cassette structure, the time-consuming and potentially error-prone pipetting of a whole blood sample is no longer necessary. The aim of this study is to develop a coagulation algorithm based on Quantra POCT for the treatment of coagulopathic cardiac surgery patients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Quantra
Evaluation of bloodsamples using the Quantra and Multiplate device
Quantra-Algorithm
Hemotherapy based on Quantra-Algorithm
Control
Evaluation of bloodsamples using the ROTEM and Multiplate device
ROTEM-Algorithm
Hemotherapy based on Basic-Algorithm
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Quantra-Algorithm
Hemotherapy based on Quantra-Algorithm
ROTEM-Algorithm
Hemotherapy based on Basic-Algorithm
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
HemoSonics LLC
INDUSTRY
Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. med. Florian Raimann
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Florian J Raimann, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Goethe University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Frankfurt
Frankfurt am Main, Hesse, Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Weber CF, Zacharowski K, Brun K, Volk T, Martin EO, Hofer S, Kreuer S. [Basic algorithm for Point-of-Care based hemotherapy: perioperative treatment of coagulopathic patients]. Anaesthesist. 2013 Jun;62(6):464-72. doi: 10.1007/s00101-013-2184-8. German.
Ferrante EA, Blasier KR, Givens TB, Lloyd CA, Fischer TJ, Viola F. A Novel Device for the Evaluation of Hemostatic Function in Critical Care Settings. Anesth Analg. 2016 Dec;123(6):1372-1379. doi: 10.1213/ANE.0000000000001413.
Viola F, Lin-Schmidt X, Bhamidipati C, Haverstick DM, Walker WF, Ailawadi G, Lawrence MB. Sonorheometry assessment of platelet function in cardiopulmonary bypass patients: Correlation of blood clot stiffness with platelet integrin alphaIIbbeta3 activity, aspirin usage, and transfusion risk. Thromb Res. 2016 Feb;138:96-102. doi: 10.1016/j.thromres.2015.11.036. Epub 2015 Nov 26.
Huffmyer JL, Fernandez LG, Haghighian C, Terkawi AS, Groves DS. Comparison of SEER Sonorheometry With Rotational Thromboelastometry and Laboratory Parameters in Cardiac Surgery. Anesth Analg. 2016 Dec;123(6):1390-1399. doi: 10.1213/ANE.0000000000001507.
Reynolds PS, Middleton P, McCarthy H, Spiess BD. A Comparison of a New Ultrasound-Based Whole Blood Viscoelastic Test (SEER Sonorheometry) Versus Thromboelastography in Cardiac Surgery. Anesth Analg. 2016 Dec;123(6):1400-1407. doi: 10.1213/ANE.0000000000001362.
Michel S, Piekarski F, Fischer JH, Hettler V, Adam EH, Holzer L, Lotz G, Walther T, Zacharowski K, Raimann FJ. Hemostatis Analyzer-Supported Hemotherapy Algorithm in Cardiac Surgery: Protocol for a Randomized Controlled Monocentric Trial. JMIR Res Protoc. 2020 Apr 21;9(4):e17206. doi: 10.2196/17206.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
42/19
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.