NCT03902275

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

July 2, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

March 26, 2019

Last Update Submit

June 30, 2020

Conditions

HemorrhageBleeding

Keywords

cardiac surgerybleedingpoint of care testingPOCTalgorithm based therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Correlations of parameters between POCT and laboratory parameters.

    During operation within 24 hours postoperative

  • Correlations of parameters between POCT and laboratory parameters.

    During operation within 24 hours postoperative

  • Correlations of parameters between POCT and laboratory parameters.

    During operation within 24 hours postoperative

  • Correlations of parameters between POCT and laboratory parameters.

    During operation within 24 hours postoperative

  • Correlations of parameters between POCT and laboratory parameters.

    During operation within 24h postoperative

  • +8 more secondary outcomes

Study Arms (2)

Quantra

EXPERIMENTAL

Evaluation of bloodsamples using the Quantra and Multiplate device

Other: Quantra-Algorithm

Control

ACTIVE COMPARATOR

Evaluation of bloodsamples using the ROTEM and Multiplate device

Other: ROTEM-Algorithm

Interventions

Quantra-AlgorithmOTHER

Hemotherapy based on Quantra-Algorithm

Quantra
ROTEM-AlgorithmOTHER

Hemotherapy based on Basic-Algorithm

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years elective operation with cardiac bypass

You may not qualify if:

  • participation on another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (6)

  • 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.

    PMID: 23793973RESULT

  • 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.

    PMID: 27224934RESULT

  • 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.

    PMID: 26688324RESULT

  • 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.

    PMID: 27749339RESULT

  • 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.

    PMID: 27159065RESULT

  • 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.

    PMID: 32314972DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Florian J Raimann, Dr. med.

    Goethe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 26, 2019

First Posted

April 4, 2019

Study Start

July 1, 2019

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

July 2, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)