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Trauma Induced CoagulopathyNCT05004844

Mitochondrial Dysfunction in Trauma-related Coagulopathy

An observational study of Trauma Induced Coagulopathy, run by Petra Hartmann MD Ph.D. at 1 site in Hungary.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Trauma Induced Coagulopathy
What is being tested?
Viscoelastic assays and aggregometry tests
How many people
40 participants
Where
1 siteHungary
Study dates
31 Oct 2021to 31 Jan 2023
Phase
Observational
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Severely injured trauma patients with hemorrhage

Who may be able to join

  • 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)

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Petra Dr. Hartmann, MD, Ph.D. contact

+36304388695

petra.hartmann@med.u-szeged.hu

Péter Dr. Jávor, M.D. contact

+36703193420

peter.javor.md.@gmail.com

Hungary1 site

  • Department of Traumatology, University of Szeged

    Szeged, 6720

    Eszter Bucsuházy, +3662545531, office.trauma@med.u-szeged.hu

    Petra Hartmann, MD, Ph.D.

Other trials in Hungary

About this study

Official title: Mitochondrial Dysfunction in Trauma-related Coagulopathy - Is There Causality? - Study Protocol for a Prospective Observational Study

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

Read the detailed description

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.

Being tested
Viscoelastic assays and aggregometry tests
Keywords
blood coagulation disorders, wounds and injuries, hemorrhage, mitochondria, blood platelet disorders, thrombelastography, coagulopathy, trauma induced
Medical subject headings
Blood Coagulation Disorders, Wounds and Injuries, Hemorrhage, Blood Platelet Disorders, Hemostatic Disorders

What participants receive

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

  • Viscoelastic assays and aggregometry testsDiagnostic test

    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.

What is being measured

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

  1. Association between mitochondrial functions and aggregation capacity of platelets

    The association between the results of high-resolution respirometry (The activity of respiratory complexes, the ATP synthase activity (OxPhos), the electron transport chain capacity and coupling of mitochondria) and numerical parameters of ROTEM aggregometry (AUC, MS and A6 in TRAPTEM) at 0, 24, 48, and 72 hours post-admission will constitute our primary outcome.

    Measured: 72 hours

Secondary outcomes (3)

  1. Association between platelet mitochondrial functions and clot formation ability

    The association between the results of high-resolution respirometry (The activity of respiratory complexes, the ATP synthase activity (OxPhos), the electron transport chain capacity and coupling of mitochondria) and results of viscoelastic assays (CT, CFT, α-angle, A10, MCF, LI30 and ML in INTEM, EXTEM, APTEM, FIBTEM) at 0, 24, 48, and 72 hours post-admission will serve as secondary outcome.

    Measured: 72 hours

  2. Association between platelet mitochondrial functions and conventional laboratory markers of hemostasis

    The association between the results of high-resolution respirometry (The activity of respiratory complexes, the ATP synthase activity (OxPhos), the electron transport chain capacity and coupling of mitochondria) and conventional markers of hemostasis (prothrombin time (PT), International Normalized Ratio (INR)) at 0, 24, 48, and 72 hours post-admission will serve as secondary outcome.

    Measured: 72 hours

  3. Relation between platelet mitochondrial functions and mortality

    The association between the results of high-resolution respirometry (The activity of respiratory complexes, the ATP synthase activity (OxPhos), the electron transport chain capacity and coupling of mitochondria) and 72-hour mortality will serve as secondary outcome.

    Measured: 72 hours

Timeline

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

  1. First posted13 Aug 2021
  2. Study start31 Oct 2021 (estimated)
  3. Primary completion31 Oct 2022 (estimated)
  4. Study completion31 Jan 2023 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05004844
Sponsor's protocol ID
5500/2021-SZTE
Status last verified
Sep 2021
First submitted
6 Aug 2021
Last updated
28 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33927200

  • 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.

    PubMed 22308457

  • 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.

    PubMed 30985957

  • 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.

    PubMed 22743367

  • 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.

    PubMed 34954696

Questions about this trial

What is this clinical trial studying?

An observational study of Trauma Induced Coagulopathy, run by Petra Hartmann MD Ph.D. at 1 site in Hungary.

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 4 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: status not confirmed, as of the sponsor's last update on 28 Sep 2021. 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 Hungary. 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?

Results are not available in the source record.

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

Contact Petra Dr. Hartmann, MD, Ph.D. (+36304388695, petra.hartmann@med.u-szeged.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association between mitochondrial functions and aggregation capacity of platelets (time frame: 72 hours). 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 NCT05004844, which also lists 5 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 28 Sep 2021.

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