Clinical trial NCT05004844: Mitochondrial Dysfunction in Trauma-related Coagulopathy
Official title: Mitochondrial Dysfunction in Trauma-related Coagulopathy - Is There Causality? - Study Protocol for a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma Induced Coagulopathy
Keywords: blood coagulation disorders
wounds and injuries
hemorrhage
mitochondria
blood platelet disorders
thrombelastography
coagulopathy, trauma induced
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severely injured trauma patients with hemorrhage

Brief 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. 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: 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Association between mitochondrial functions and aggregation capacity of platelets
timeFrame: 72 hours
Secondary outcomes:
measure: Association between platelet mitochondrial functions and clot formation ability
timeFrame: 72 hours
measure: Association between platelet mitochondrial functions and conventional laboratory markers of hemostasis
timeFrame: 72 hours
measure: Relation between platelet mitochondrial functions and mortality
timeFrame: 72 hours
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: Department of Traumatology, University of Szeged
Study officials:
affiliation: Department of Traumatology, University of Szeged
name: Endre Prof. Dr. Varga, M.D,Ph.D,DSc
role: STUDY_DIRECTOR
affiliation: Department of Traumatology, University of Szeged
name: Petra Dr. Hartmann, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.