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Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT03902275
Recruitment Status : Terminated (SARS-CoV-2 Pandemic)
First Posted : April 4, 2019
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
HemoSonics LLC
Information provided by (Responsible Party):
Dr. med. Florian Raimann, Johann Wolfgang Goethe University Hospital

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.

Condition or disease Intervention/treatment Phase
Hemorrhage Bleeding Other: Quantra-Algorithm Other: ROTEM-Algorithm Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Bloodloss [ Time Frame: From finishing operation until 24 hours postoperative ]
    Cumulative bloodloss directly after surgery for 24h Determined by cumulative volume of all drains in millilitres


Secondary Outcome Measures :
  1. Correlations of parameters between POCT and laboratory parameters. [ Time Frame: During operation within 24 hours postoperative ]
    Quick

  2. Correlations of parameters between POCT and laboratory parameters. [ Time Frame: During operation within 24 hours postoperative ]
    prothrombine time

  3. Correlations of parameters between POCT and laboratory parameters. [ Time Frame: During operation within 24 hours postoperative ]
    activated partial thromboplastin time

  4. Correlations of parameters between POCT and laboratory parameters. [ Time Frame: During operation within 24 hours postoperative ]
    Firbinogen

  5. Correlations of parameters between POCT and laboratory parameters. [ Time Frame: During operation within 24h postoperative ]
    platelet count

  6. Multiplate results [ Time Frame: During operation within 24 hours postoperative ]
    Determin platelet function with TRAP test

  7. Multiplate results [ Time Frame: During operation within 24 hours postoperative ]
    Determin platelet function with ASPI test

  8. Multiplate results [ Time Frame: During operation within 24 hours postoperative ]
    Determin platelet function with ADP test

  9. Time saving by using a cassette [ Time Frame: During operation within 24 hours postoperative ]
    Influence of a cassette structure in comparison to pipetting with regard to the temporal availability of the measurement results

  10. Use of blood products [ Time Frame: During operation within 24 hours postoperative ]
    Cumulative volume of administered fresh frozen plasma, platelet infusion and packed red blood cells in mililitres

  11. Coagulationfactos and procoagulant drugs [ Time Frame: During operation within 24 hours postoperative ]
    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

  12. Thromboembolic complications [ Time Frame: During operation within 24h postoperative ]
    Thromboembolic complications

  13. Comorbidities [ Time Frame: 15 years before operation ]
    Comorbidities



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

>18 years elective operation with cardiac bypass

Exclusion Criteria:

participation on another study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902275


Locations
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Germany
University Hospital Frankfurt
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
HemoSonics LLC
Investigators
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Principal Investigator: Florian J Raimann, Dr. med. University Hospital, Frankfurt
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. med. Florian Raimann, Principal investigator, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT03902275    
Other Study ID Numbers: 42/19
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. med. Florian Raimann, Johann Wolfgang Goethe University Hospital:
cardiac surgery
bleeding
point of care testing
POCT
algorithm based therapy
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes