Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery
Primary Purpose
Hemorrhage, Bleeding
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Quantra-Algorithm
ROTEM-Algorithm
Sponsored by

About this trial
This is an interventional treatment trial for Hemorrhage focused on measuring cardiac surgery, bleeding, point of care testing, POCT, algorithm based therapy
Eligibility Criteria
Inclusion Criteria:
>18 years elective operation with cardiac bypass
Exclusion Criteria:
participation on another study
Sites / Locations
- University Hospital Frankfurt
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Quantra
Control
Arm Description
Evaluation of bloodsamples using the Quantra and Multiplate device
Evaluation of bloodsamples using the ROTEM and Multiplate device
Outcomes
Primary Outcome Measures
Bloodloss
Cumulative bloodloss directly after surgery for 24h Determined by cumulative volume of all drains in millilitres
Secondary Outcome Measures
Correlations of parameters between POCT and laboratory parameters.
Quick
Correlations of parameters between POCT and laboratory parameters.
prothrombine time
Correlations of parameters between POCT and laboratory parameters.
activated partial thromboplastin time
Correlations of parameters between POCT and laboratory parameters.
Firbinogen
Correlations of parameters between POCT and laboratory parameters.
platelet count
Multiplate results
Determin platelet function with TRAP test
Multiplate results
Determin platelet function with ASPI test
Multiplate results
Determin platelet function with ADP test
Time saving by using a cassette
Influence of a cassette structure in comparison to pipetting with regard to the temporal availability of the measurement results
Use of blood products
Cumulative volume of administered fresh frozen plasma, platelet infusion and packed red blood cells in mililitres
Coagulationfactos and procoagulant drugs
Cumulative usage of prothrombin complexe concentrate measured in international units, fibrinogen measured in gramm, tranexamic acid measured in gramm, desmopressin measured in microgramm, Calcium measured in gramm, activated factor VII measured in international units
Thromboembolic complications
Thromboembolic complications
Comorbidities
Comorbidities
Full Information
NCT ID
NCT03902275
First Posted
March 26, 2019
Last Updated
June 30, 2020
Sponsor
Johann Wolfgang Goethe University Hospital
Collaborators
HemoSonics LLC
1. Study Identification
Unique Protocol Identification Number
NCT03902275
Brief Title
Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery
Official Title
Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
SARS-CoV-2 Pandemic
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
Collaborators
HemoSonics LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to develop a coagulation algorithm based on Quantra POCT for the treatment of coagulopathic cardiac surgery patients.
Detailed Description
In order to perform a targeted coagulation therapy during intra- and postoperative care of cardiosurgical patients, it is necessary to know the hemostatic potential. After blood samples have been taken for coagulation diagnosis, they are usually sent to the central laboratory. After analysis and validation, the results are transmitted electronically. The loss of time due to sample transport, analysis and provision of the results prolongs the time required to derive therapeutic measures.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Bleeding
Keywords
cardiac surgery, bleeding, point of care testing, POCT, algorithm based therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quantra
Arm Type
Experimental
Arm Description
Evaluation of bloodsamples using the Quantra and Multiplate device
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Evaluation of bloodsamples using the ROTEM and Multiplate device
Intervention Type
Other
Intervention Name(s)
Quantra-Algorithm
Intervention Description
Hemotherapy based on Quantra-Algorithm
Intervention Type
Other
Intervention Name(s)
ROTEM-Algorithm
Intervention Description
Hemotherapy based on Basic-Algorithm
Primary Outcome Measure Information:
Title
Bloodloss
Description
Cumulative bloodloss directly after surgery for 24h Determined by cumulative volume of all drains in millilitres
Time Frame
From finishing operation until 24 hours postoperative
Secondary Outcome Measure Information:
Title
Correlations of parameters between POCT and laboratory parameters.
Description
Quick
Time Frame
During operation within 24 hours postoperative
Title
Correlations of parameters between POCT and laboratory parameters.
Description
prothrombine time
Time Frame
During operation within 24 hours postoperative
Title
Correlations of parameters between POCT and laboratory parameters.
Description
activated partial thromboplastin time
Time Frame
During operation within 24 hours postoperative
Title
Correlations of parameters between POCT and laboratory parameters.
Description
Firbinogen
Time Frame
During operation within 24 hours postoperative
Title
Correlations of parameters between POCT and laboratory parameters.
Description
platelet count
Time Frame
During operation within 24h postoperative
Title
Multiplate results
Description
Determin platelet function with TRAP test
Time Frame
During operation within 24 hours postoperative
Title
Multiplate results
Description
Determin platelet function with ASPI test
Time Frame
During operation within 24 hours postoperative
Title
Multiplate results
Description
Determin platelet function with ADP test
Time Frame
During operation within 24 hours postoperative
Title
Time saving by using a cassette
Description
Influence of a cassette structure in comparison to pipetting with regard to the temporal availability of the measurement results
Time Frame
During operation within 24 hours postoperative
Title
Use of blood products
Description
Cumulative volume of administered fresh frozen plasma, platelet infusion and packed red blood cells in mililitres
Time Frame
During operation within 24 hours postoperative
Title
Coagulationfactos and procoagulant drugs
Description
Cumulative usage of prothrombin complexe concentrate measured in international units, fibrinogen measured in gramm, tranexamic acid measured in gramm, desmopressin measured in microgramm, Calcium measured in gramm, activated factor VII measured in international units
Time Frame
During operation within 24 hours postoperative
Title
Thromboembolic complications
Description
Thromboembolic complications
Time Frame
During operation within 24h postoperative
Title
Comorbidities
Description
Comorbidities
Time Frame
15 years before operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
>18 years elective operation with cardiac bypass
Exclusion Criteria:
participation on another study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian J Raimann, Dr. med.
Organizational Affiliation
Goethe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Frankfurt
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23793973
Citation
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.
Results Reference
result
PubMed Identifier
27224934
Citation
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.
Results Reference
result
PubMed Identifier
26688324
Citation
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.
Results Reference
result
PubMed Identifier
27749339
Citation
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.
Results Reference
result
PubMed Identifier
27159065
Citation
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.
Results Reference
result
PubMed Identifier
32314972
Citation
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.
Results Reference
derived
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Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery
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