Major Burns Coagulation and the Role of Factor XIII: A Descriptive Study
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-Summary
Prospective observational study in which FXIII levels and coagulation tests and cicatrization are measured during the 30 days after the thermal trauma.
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+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.
+Arms and interventions
- Coagulation tests (Diagnostic test), also known as Cicatrization 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
+Outcome measures
Primary outcomes
- Factor XIII [30 days]: Blood Coagulation Factor XIII levels
Secondary outcomes
- Prothrombin Time (PT) [30 days]: Prothrombin Time blood levels
- Activated Partial Thromboplastin Time (APTT) [30 days]: Activated Partial Thromboplastin Time blood levels
- Thrombin Time (TT) [30 days]: Thrombin Time blood levels
- Fibrinogen [30 days]: Functional fibrinogen blood levels
- Lactate [30 days]: Lactate blood levels
- Base Excess (BE) [30 days]: Base Excess blood levels
- Fibrin monomers [30 days]: Fibrin monomers blood levels
- Factor XII [30 days]: Factor XII blood levels
- Factor VIII [30 days]: Factor VIII blood levels
- Factor von Willebrand [30 days]: Factor von Willebrand blood levels
- Plasmin [30 days]: Plasmin blood levels
- Plasminogen [30 days]: Plasminogen blood levels
- Alpha-2-antiplasmin [30 days]: Alpha-2-antiplasmin blood levels
- Antithrombin (AT) [30 days]: Antithrombin blood levels
- Protein C [30 days]: Protein C blood levels
- Heparan sulfate [30 days]: Heparan sulfate blood levels
- Syndecan 1 [30 days]: Syndecan 1 blood levels
- Healing Vancouver test [30 days]: The Vancouver survey will be conducted on the state of healing
- Healing POSAS test [30 days]: The POSAS survey will be conducted on the state of healing
- Tewamether moisture titration [30 days]: Tewamether consists of two pairs of sensors to measure the humidity and temperature gradients in two different spacings
- Surgical bleeding survey [10 days]: A surgical team survey will be performed on intraoperative bleeding (during the first debridal surgery)
- Reintervention due to bleeding [11 days]: The need of reintervention because of bleeding within the next 24 hours after the first debridal surgery will be registered
- Surface debrided [10 days]: The percentage of debrided surface and type of debridement (in the first debriding surgery)
- Surgery Bleeding [15 days]: Estimated bleeding according to the modified Gross formula (in the first debriding surgery)
+Eligibility
Sex: All, ages: 18 Years to any
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
+Publications
- 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. PMID 27543523
- 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. PMID 26854881
- 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. PMID 24996247
- 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. PMID 23498713
- 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. PMID 20689402
- 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. PMID 22677221
- 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. PMID 18193192
- 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. PMID 16879922
- 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. PMID 15774294
- 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. PMID 11525850
- 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. PMID 20236770
- 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. PMID 22113102
- 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. PMID 15281516
- Korte W. [Fibrin monomer and factor XIII: a new concept for unexplained intraoperative coagulopathy]. Hamostaseologie. 2006 Aug;26(3 Suppl 1):S30-5. German. PMID 16953290
- 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. PMID 19762725
+Investigators