Mitochondrial Dysfunction in Trauma-related Coagulopathy

NCT ID: NCT05004844

Last Updated: 2021-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-31

Study Completion Date

2023-01-31

Brief Summary

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Bleeding control often poses a great challenge for clinicians due to trauma-induced blood clotting disorder (TIC), a condition that is present in one-third of bleeding trauma patients. As platelets are considered as central mediators in TIC, the understanding of mitochondria-mediated processes in thrombocytes may disclose new therapeutic targets in the management of severely injured patients. The investigators hypothesize that mitochondrial dysfunction occurs in the platelets of trauma patients with TIC. The investigators intend to quantitatively characterize the derangements of mitochondrial functions in TIC; and assess the relation between mitochondrial respiration and clinical markers of platelet function

Detailed Description

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Hemorrhage control often poses a great challenge for clinicians due to trauma-induced coagulopathy (TIC), a condition that is present in one-third of bleeding trauma patients. As platelets are considered as central mediators in TIC, the understanding of mitochondria-mediated processes in thrombocytes may disclose new therapeutic targets in the management of severely injured patients. The investigators hypothesize that mitochondrial dysfunction occurs in the platelets of trauma patients with TIC. The investigators intend to quantitatively characterize the derangements of mitochondrial functions in TIC; and assess the relation between mitochondrial respiration and clinical markers of platelet function measured with aggregometry, viscoelastic tests and conventional laboratory analysis.

Conditions

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Trauma Induced Coagulopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Viscoelastic assays and aggregometry tests

Viscoelastic assays and aggregometry tests performed with ROTEM will allow us to characterize the clot forming abilities and platelet functions of our patients. ROTEM is used routinely for aiding clinicians in choosing the appropriate blood products for patients ROTEM requires samples of whole blood in an amount that does not entail additional burden or risk for patients. In our study, viscoelastic assays and aggregometry will be performed upon arrival, and 24-,48-,72-hours post-admission.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Trauma patients
* Injury Severity Score (ISS) 16 or greater,
* age of 18 years or greater,
* hemorrhage confirmed with extended focused assessment with sonography in trauma (eFAST) or computer tomography (CT)

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Petra Hartmann MD Ph.D.

OTHER

Sponsor Role lead

Responsible Party

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Petra Hartmann MD Ph.D.

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Endre Prof. Dr. Varga, M.D,Ph.D,DSc

Role: STUDY_DIRECTOR

Department of Traumatology, University of Szeged

Petra Dr. Hartmann, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Traumatology, University of Szeged

Locations

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Department of Traumatology, University of Szeged

Szeged, , Hungary

Site Status

Countries

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Hungary

Central Contacts

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Petra Dr. Hartmann, MD, Ph.D.

Role: CONTACT

+36304388695

Péter Dr. Jávor, M.D.

Role: CONTACT

+36703193420

Facility Contacts

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Eszter Bucsuházy

Role: primary

+3662545531

References

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Moore EE, Moore HB, Kornblith LZ, Neal MD, Hoffman M, Mutch NJ, Schochl H, Hunt BJ, Sauaia A. Trauma-induced coagulopathy. Nat Rev Dis Primers. 2021 Apr 29;7(1):30. doi: 10.1038/s41572-021-00264-3.

Reference Type BACKGROUND
PMID: 33927200 (View on PubMed)

Barile CJ, Herrmann PC, Tyvoll DA, Collman JP, Decreau RA, Bull BS. Inhibiting platelet-stimulated blood coagulation by inhibition of mitochondrial respiration. Proc Natl Acad Sci U S A. 2012 Feb 14;109(7):2539-43. doi: 10.1073/pnas.1120645109. Epub 2012 Jan 30.

Reference Type BACKGROUND
PMID: 22308457 (View on PubMed)

Kornblith LZ, Moore HB, Cohen MJ. Trauma-induced coagulopathy: The past, present, and future. J Thromb Haemost. 2019 Jun;17(6):852-862. doi: 10.1111/jth.14450. Epub 2019 May 13.

Reference Type BACKGROUND
PMID: 30985957 (View on PubMed)

Kutcher ME, Redick BJ, McCreery RC, Crane IM, Greenberg MD, Cachola LM, Nelson MF, Cohen MJ. Characterization of platelet dysfunction after trauma. J Trauma Acute Care Surg. 2012 Jul;73(1):13-9. doi: 10.1097/TA.0b013e318256deab.

Reference Type BACKGROUND
PMID: 22743367 (View on PubMed)

Javor P, Rarosi F, Horvath T, Torok L, Hartmann P. Mitochondrial Dysfunction in Trauma-Related Coagulopathy: Is There Causality? Study Protocol for a Prospective Observational Study. Eur Surg Res. 2023;64(2):304-309. doi: 10.1159/000521670. Epub 2021 Dec 24.

Reference Type DERIVED
PMID: 34954696 (View on PubMed)

Other Identifiers

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5500/2021-SZTE

Identifier Type: -

Identifier Source: org_study_id

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