Clinical trial NCT03188913: Factor XIII in Major Burns Coagulation
Official title: Major Burns Coagulation and the Role of Factor XIII: A Descriptive Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Burns
Coagulation Disorder
Factor XIII Deficiency
Cicatrization
Endothelial Dysfunction
Keywords: Burns
Coagulation
Factor XIII
Glycocalix
Cicatrization
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Burned patients over 18 years of age with a burned body surface of 20% or more admitted to the burn unit of the Vall d'Hebron University Hospital from the start of the study to the end of the study with surgical burns ( Second grade or third grade) and for whom informed consent has been obtained

Brief summary: Prospective observational study in which FXIII levels and coagulation tests and cicatrization are measured during the 30 days after the thermal trauma.

Detailed description: This is a prospective observational pilot study in which the levels of FXIII and coagulation, anticoagulation, fibrinolysis, endothelial tissue damage and cicatrization are at the arrival of the patient to hospital, 24 hours before the first surgical intervention, 24h After the first surgical intervention, at 7 days after the first intervention and at 30 days after the thermal trauma, in this moment the healing will also be evaluated. All burn patients who meet the proposed inclusion criteria will be included and entered into the Burn Unit of the Vall d'Hebron University Hospital from the start of the study until reaching a minimum of 20 cases or a temporary term of 2 years.

Eligibility criteria: Inclusion Criteria:

* Burned patients with a burned body surface of 20% or more
* Over 18 years of age

Exclusion Criteria:

* ABSI (Abbreviated Burns Severity Index) greater than or equal to 12
* Associated polytrauma
* Coagulation deficit previously known
* Treatment with anticoagulants
* Electrocution burns
* Admission into the unit after hour 6 after thermal trauma
* The refusal of the patient, familiar or responsible to participate in the study

Primary outcomes:
measure: Factor XIII
timeFrame: 30 days
Secondary outcomes:
measure: Prothrombin Time (PT)
timeFrame: 30 days
measure: Activated Partial Thromboplastin Time (APTT)
timeFrame: 30 days
measure: Thrombin Time (TT)
timeFrame: 30 days
measure: Fibrinogen
timeFrame: 30 days
measure: Lactate
timeFrame: 30 days
measure: Base Excess (BE)
timeFrame: 30 days
measure: Fibrin monomers
timeFrame: 30 days
measure: Factor XII
timeFrame: 30 days
measure: Factor VIII
timeFrame: 30 days
measure: Factor von Willebrand
timeFrame: 30 days
measure: Plasmin
timeFrame: 30 days
measure: Plasminogen
timeFrame: 30 days
measure: Alpha-2-antiplasmin
timeFrame: 30 days
measure: Antithrombin (AT)
timeFrame: 30 days
measure: Protein C
timeFrame: 30 days
measure: Heparan sulfate
timeFrame: 30 days
measure: Syndecan 1
timeFrame: 30 days
measure: Healing Vancouver test
timeFrame: 30 days
measure: Healing POSAS test
timeFrame: 30 days
measure: Tewamether moisture titration
timeFrame: 30 days
measure: Surgical bleeding survey
timeFrame: 10 days
measure: Reintervention due to bleeding
timeFrame: 11 days
measure: Surface debrided
timeFrame: 10 days
measure: Surgery Bleeding
timeFrame: 15 days
Other outcomes:
Locations:
Study officials:
affiliation: Vall d'Hebron Universitary Hospital
name: Patricia Guilabert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guilabert P, Usua G, Martin N, Abarca L, Barret JP, Colomina MJ. Fluid resuscitation management in patients with burns: update. Br J Anaesth. 2016 Sep;117(3):284-96. doi: 10.1093/bja/aew266.
citation: Glas GJ, Levi M, Schultz MJ. Coagulopathy and its management in patients with severe burns. J Thromb Haemost. 2016 May;14(5):865-74. doi: 10.1111/jth.13283. Epub 2016 Mar 23.
citation: Sherren PB, Hussey J, Martin R, Kundishora T, Parker M, Emerson B. Lethal triad in severe burns. Burns. 2014 Dec;40(8):1492-6. doi: 10.1016/j.burns.2014.04.011. Epub 2014 Jul 1.
citation: Sherren PB, Hussey J, Martin R, Kundishora T, Parker M, Emerson B. Acute burn induced coagulopathy. Burns. 2013 Sep;39(6):1157-61. doi: 10.1016/j.burns.2013.02.010. Epub 2013 Mar 14.
citation: King DR, Namias N, Andrews DM. Coagulation abnormalities following thermal injury. Blood Coagul Fibrinolysis. 2010 Oct;21(7):666-9. doi: 10.1097/MBC.0b013e32833ceb08.
citation: Mitra B, Wasiak J, Cameron PA, O'Reilly G, Dobson H, Cleland H. Early coagulopathy of major burns. Injury. 2013 Jan;44(1):40-3. doi: 10.1016/j.injury.2012.05.010. Epub 2012 Jun 5.
citation: Lavrentieva A, Kontakiotis T, Bitzani M, Papaioannou-Gaki G, Parlapani A, Thomareis O, Tsotsolis N, Giala MA. Early coagulation disorders after severe burn injury: impact on mortality. Intensive Care Med. 2008 Apr;34(4):700-6. doi: 10.1007/s00134-007-0976-5. Epub 2008 Jan 12.
citation: Barret JP, Dziewulski PG. Complications of the hypercoagulable status in burn injury. Burns. 2006 Dec;32(8):1005-8. doi: 10.1016/j.burns.2006.02.018. Epub 2006 Aug 1.
citation: Barret JP, Gomez PA. Disseminated intravascular coagulation: a rare entity in burn injury. Burns. 2005 May;31(3):354-7. doi: 10.1016/j.burns.2004.11.006. Epub 2005 Jan 21.
citation: Aoki K, Aikawa N, Sekine K, Yamazaki M, Mimura T, Urano T, Takada A. Elevation of plasma free PAI-1 levels as an integrated endothelial response to severe burns. Burns. 2001 Sep;27(6):569-75. doi: 10.1016/s0305-4179(01)00011-0.
citation: Levin GY, Egorihina MN. The role of fibrinogen in aggregation of platelets in burn injury. Burns. 2010 Sep;36(6):806-10. doi: 10.1016/j.burns.2009.05.005. Epub 2010 Mar 16.
citation: Schaden E, Hoerburger D, Hacker S, Kraincuk P, Baron DM, Kozek-Langenecker S. Fibrinogen function after severe burn injury. Burns. 2012 Feb;38(1):77-82. doi: 10.1016/j.burns.2010.12.004. Epub 2011 Nov 23.
citation: Nielsen VG, Gurley WQ Jr, Burch TM. The impact of factor XIII on coagulation kinetics and clot strength determined by thrombelastography. Anesth Analg. 2004 Jul;99(1):120-123. doi: 10.1213/01.ANE.0000123012.24871.62.
citation: Korte W. [Fibrin monomer and factor XIII: a new concept for unexplained intraoperative coagulopathy]. Hamostaseologie. 2006 Aug;26(3 Suppl 1):S30-5. German.
citation: Jambor C, Reul V, Schnider TW, Degiacomi P, Metzner H, Korte WC. In vitro inhibition of factor XIII retards clot formation, reduces clot firmness, and increases fibrinolytic effects in whole blood. Anesth Analg. 2009 Oct;109(4):1023-8. doi: 10.1213/ANE.0b013e3181b5a263.