Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery

The aim of this study is to develop a coagulation algorithm based on Quantra POCT for the treatment of coagulopathic cardiac surgery patients.

Study Overview

• Status: Terminated
• Conditions: Hemorrhage; Bleeding
• Intervention / Treatment: Other: Quantra-Algorithm; Other: ROTEM-Algorithm

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • University Hospital Frankfurt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

>18 years elective operation with cardiac bypass

Exclusion Criteria:

participation on another study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quantra; Evaluation of bloodsamples using the Quantra and Multiplate device	Other: Quantra-Algorithm; Hemotherapy based on Quantra-Algorithm
Active Comparator: Control; Evaluation of bloodsamples using the ROTEM and Multiplate device	Other: ROTEM-Algorithm; Hemotherapy based on Basic-Algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bloodloss	Cumulative bloodloss directly after surgery for 24h Determined by cumulative volume of all drains in millilitres	From finishing operation until 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlations of parameters between POCT and laboratory parameters.	Quick	During operation within 24 hours postoperative
Correlations of parameters between POCT and laboratory parameters.	prothrombine time	During operation within 24 hours postoperative
Correlations of parameters between POCT and laboratory parameters.	activated partial thromboplastin time	During operation within 24 hours postoperative
Correlations of parameters between POCT and laboratory parameters.	Firbinogen	During operation within 24 hours postoperative
Correlations of parameters between POCT and laboratory parameters.	platelet count	During operation within 24h postoperative
Multiplate results	Determin platelet function with TRAP test	During operation within 24 hours postoperative
Multiplate results	Determin platelet function with ASPI test	During operation within 24 hours postoperative
Multiplate results	Determin platelet function with ADP test	During operation within 24 hours postoperative
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	During operation within 24 hours postoperative
Use of blood products	Cumulative volume of administered fresh frozen plasma, platelet infusion and packed red blood cells in mililitres	During operation within 24 hours postoperative
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	During operation within 24 hours postoperative
Thromboembolic complications	Thromboembolic complications	During operation within 24h postoperative
Comorbidities	Comorbidities	15 years before operation

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital
• Collaborators: HemoSonics LLC
• Investigators: Principal Investigator: Florian J Raimann, Dr. med., University Hospital Frankfurt

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: cardiac surgery; bleeding; POCT; point of care testing; algorithm based therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 42/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No