Clinical trial NCT03902275: 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
Overall status: TERMINATED
Phase: NA
Conditions: Hemorrhage
Bleeding
Keywords: cardiac surgery
bleeding
point of care testing
POCT
algorithm based therapy
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: HemoSonics LLC
First posted: 2019-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

\>18 years elective operation with cardiac bypass

Exclusion Criteria:

participation on another study

Primary outcomes:
measure: Bloodloss
timeFrame: From finishing operation until 24 hours postoperative
Secondary outcomes:
measure: Correlations of parameters between POCT and laboratory parameters.
timeFrame: During operation within 24 hours postoperative
measure: Correlations of parameters between POCT and laboratory parameters.
timeFrame: During operation within 24 hours postoperative
measure: Correlations of parameters between POCT and laboratory parameters.
timeFrame: During operation within 24 hours postoperative
measure: Correlations of parameters between POCT and laboratory parameters.
timeFrame: During operation within 24 hours postoperative
measure: Correlations of parameters between POCT and laboratory parameters.
timeFrame: During operation within 24h postoperative
measure: Multiplate results
timeFrame: During operation within 24 hours postoperative
measure: Multiplate results
timeFrame: During operation within 24 hours postoperative
measure: Multiplate results
timeFrame: During operation within 24 hours postoperative
measure: Time saving by using a cassette
timeFrame: During operation within 24 hours postoperative
measure: Use of blood products
timeFrame: During operation within 24 hours postoperative
measure: Coagulationfactos and procoagulant drugs
timeFrame: During operation within 24 hours postoperative
measure: Thromboembolic complications
timeFrame: During operation within 24h postoperative
measure: Comorbidities
timeFrame: 15 years before operation
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: University Hospital Frankfurt
state: Hessen
Study officials:
affiliation: Goethe University
name: Florian J Raimann, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.