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HemorrhageNCT03902275

Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery

A study testing Quantra-Algorithm and ROTEM-Algorithm in people with Hemorrhage and Bleeding, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hemorrhage, Bleeding
What is being tested?
Quantra-Algorithm and ROTEM-Algorithm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteGermany
Study dates
1 Jul 2019to 1 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • >18 years elective operation with cardiac bypass

Who cannot join

  • participation on another study

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Frankfurt

    Frankfurt am Main, Hesse, 60590

Other trials in Germany

About this study

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

Read the 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.

Conditions
Hemorrhage, Bleeding
Being tested
Quantra-Algorithm, ROTEM-Algorithm
Keywords
cardiac surgery, bleeding, point of care testing, POCT, algorithm based therapy
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quantra-AlgorithmOther

    Hemotherapy based on Quantra-Algorithm

  • ROTEM-AlgorithmOther

    Hemotherapy based on Basic-Algorithm

Study groups in NCT03902275
Study groupRoleWhat they receive
QuantraExperimentalEvaluation of bloodsamples using the Quantra and Multiplate device
Receives: Other: Quantra-Algorithm
ControlActive comparatorEvaluation of bloodsamples using the ROTEM and Multiplate device
Receives: Other: ROTEM-Algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bloodloss

    Cumulative bloodloss directly after surgery for 24h Determined by cumulative volume of all drains in millilitres

    Measured: From finishing operation until 24 hours postoperative

Secondary outcomes (13)

  1. Correlations of parameters between POCT and laboratory parameters.

    Quick

    Measured: During operation within 24 hours postoperative

  2. Correlations of parameters between POCT and laboratory parameters.

    prothrombine time

    Measured: During operation within 24 hours postoperative

  3. Correlations of parameters between POCT and laboratory parameters.

    activated partial thromboplastin time

    Measured: During operation within 24 hours postoperative

  4. Correlations of parameters between POCT and laboratory parameters.

    Firbinogen

    Measured: During operation within 24 hours postoperative

  5. Correlations of parameters between POCT and laboratory parameters.

    platelet count

    Measured: During operation within 24h postoperative

  6. Multiplate results

    Determin platelet function with TRAP test

    Measured: During operation within 24 hours postoperative

  7. Multiplate results

    Determin platelet function with ASPI test

    Measured: During operation within 24 hours postoperative

  8. Multiplate results

    Determin platelet function with ADP test

    Measured: During operation within 24 hours postoperative

  9. 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

    Measured: During operation within 24 hours postoperative

  10. Use of blood products

    Cumulative volume of administered fresh frozen plasma, platelet infusion and packed red blood cells in mililitres

    Measured: During operation within 24 hours postoperative

  11. 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

    Measured: During operation within 24 hours postoperative

  12. Thromboembolic complications

    Thromboembolic complications

    Measured: During operation within 24h postoperative

  13. Comorbidities

    Comorbidities

    Measured: 15 years before operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2019
  2. Study start1 Jul 2019
  3. Primary completion1 Dec 2019
  4. Study completion1 Jun 2020

Why it stopped: SARS-CoV-2 Pandemic

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03902275
Sponsor's protocol ID
42/19
Status last verified
Jun 2020
First submitted
26 Mar 2019
Last updated
2 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 23793973

  • 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.

    PubMed 27224934

  • 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.

    PubMed 26688324

  • 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.

    PubMed 27749339

  • 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.

    PubMed 27159065

  • 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.

    PubMed 32314972

Questions about this trial

What is this clinical trial studying?

A study testing Quantra-Algorithm and ROTEM-Algorithm in people with Hemorrhage and Bleeding, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: SARS-CoV-2 Pandemic). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bloodloss (time frame: From finishing operation until 24 hours postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03902275, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.

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