Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery

Bleeding Clinical Trial

Official title:

Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03902275
• Other study ID #: 42/19
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2020
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

>18 years elective operation with cardiac bypass

Exclusion Criteria:

participation on another study

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Intervention

Other:
• Quantra-Algorithm
Hemotherapy based on Quantra-Algorithm
• ROTEM-Algorithm
Hemotherapy based on Basic-Algorithm

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt	Frankfurt am Main	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital	HemoSonics LLC

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View 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. — View 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. — View 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 aIIbß3 activity, aspirin — View Citation

Weber CF, Zacharowski K, Brün 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. Review. G — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlations of parameters between POCT and laboratory parameters.	Quick	During operation within 24 hours postoperative
Secondary	Correlations of parameters between POCT and laboratory parameters.	prothrombine time	During operation within 24 hours postoperative
Secondary	Correlations of parameters between POCT and laboratory parameters.	activated partial thromboplastin time	During operation within 24 hours postoperative
Secondary	Correlations of parameters between POCT and laboratory parameters.	Firbinogen	During operation within 24 hours postoperative
Secondary	Correlations of parameters between POCT and laboratory parameters.	platelet count	During operation within 24h postoperative
Secondary	Multiplate results	Determin platelet function with TRAP test	During operation within 24 hours postoperative
Secondary	Multiplate results	Determin platelet function with ASPI test	During operation within 24 hours postoperative
Secondary	Multiplate results	Determin platelet function with ADP test	During operation within 24 hours postoperative
Secondary	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
Secondary	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
Secondary	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
Secondary	Thromboembolic complications	Thromboembolic complications	During operation within 24h postoperative
Secondary	Comorbidities	Comorbidities	15 years before operation