Factor XIII in Major Burns Coagulation

Overview

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

Full Title of Study: “Major Burns Coagulation and the Role of Factor XIII: A Descriptive Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 19, 2019

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.

Interventions

  • Diagnostic Test: Coagulation tests
    • The following plasma values will be measured: prothrombin time, activated partial thromboplastin time, thrombin time, functional fibrinogen, lactate, base excess, fibrin monomers, Factor XIII, Factor XII, Factor VIII, Fact von Willebrand, Plasmin, Plasminogen, Alpha-2-antiplasmin, antithrombin, protein C, Heparan sulfate, synecan 1. Surveys on the state of healing and moisture titration will be performed using Tewamether

Clinical Trial Outcome Measures

Primary Measures

  • Factor XIII
    • Time Frame: 30 days
    • Blood Coagulation Factor XIII levels

Secondary Measures

  • Prothrombin Time (PT)
    • Time Frame: 30 days
    • Prothrombin Time blood levels
  • Activated Partial Thromboplastin Time (APTT)
    • Time Frame: 30 days
    • Activated Partial Thromboplastin Time blood levels
  • Thrombin Time (TT)
    • Time Frame: 30 days
    • Thrombin Time blood levels
  • Fibrinogen
    • Time Frame: 30 days
    • Functional fibrinogen blood levels
  • Lactate
    • Time Frame: 30 days
    • Lactate blood levels
  • Base Excess (BE)
    • Time Frame: 30 days
    • Base Excess blood levels
  • Fibrin monomers
    • Time Frame: 30 days
    • Fibrin monomers blood levels
  • Factor XII
    • Time Frame: 30 days
    • Factor XII blood levels
  • Factor VIII
    • Time Frame: 30 days
    • Factor VIII blood levels
  • Factor von Willebrand
    • Time Frame: 30 days
    • Factor von Willebrand blood levels
  • Plasmin
    • Time Frame: 30 days
    • Plasmin blood levels
  • Plasminogen
    • Time Frame: 30 days
    • Plasminogen blood levels
  • Alpha-2-antiplasmin
    • Time Frame: 30 days
    • Alpha-2-antiplasmin blood levels
  • Antithrombin (AT)
    • Time Frame: 30 days
    • Antithrombin blood levels
  • Protein C
    • Time Frame: 30 days
    • Protein C blood levels
  • Heparan sulfate
    • Time Frame: 30 days
    • Heparan sulfate blood levels
  • Syndecan 1
    • Time Frame: 30 days
    • Syndecan 1 blood levels
  • Healing Vancouver test
    • Time Frame: 30 days
    • The Vancouver survey will be conducted on the state of healing
  • Healing POSAS test
    • Time Frame: 30 days
    • The POSAS survey will be conducted on the state of healing
  • Tewamether moisture titration
    • Time Frame: 30 days
    • Tewamether consists of two pairs of sensors to measure the humidity and temperature gradients in two different spacings
  • Surgical bleeding survey
    • Time Frame: 10 days
    • A surgical team survey will be performed on intraoperative bleeding (during the first debridal surgery)
  • Reintervention due to bleeding
    • Time Frame: 11 days
    • The need of reintervention because of bleeding within the next 24 hours after the first debridal surgery will be registered
  • Surface debrided
    • Time Frame: 10 days
    • The percentage of debrided surface and type of debridement (in the first debriding surgery)
  • Surgery Bleeding
    • Time Frame: 15 days
    • Estimated bleeding according to the modified Gross formula (in the first debriding surgery)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Universitari Vall d’Hebron Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Patricia Guilabert, MD, Principal Investigator, Vall d’Hebron Universitary Hospital
  • Overall Contact(s)
    • Patricia Guilabert, MD, 0034934 89 30 00, patricia.guilabert@gmail.com

References

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Korte W. [Fibrin monomer and factor XIII: a new concept for unexplained intraoperative coagulopathy]. Hamostaseologie. 2006 Aug;26(3 Suppl 1):S30-5. German.

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.

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