Factor XIII in Major Burns Coagulation

NCT03188913 | Unknown

• 1 other identifier: PR(ATR)341/2016
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Burns; Coagulation Disorder; Factor XIII Deficiency; Cicatrization; Endothelial Dysfunction

Keywords

Burns; Coagulation; Factor XIII; Glycocalix; Cicatrization

Outcome Measures

Primary Outcomes (1)

• Factor XIII

  Blood Coagulation Factor XIII levels

  30 days

Secondary Outcomes (24)

• Prothrombin Time (PT)

  30 days

• Activated Partial Thromboplastin Time (APTT)

  30 days

• Thrombin Time (TT)

  30 days

• Fibrinogen

  30 days

• Lactate

  30 days

Interventions

Coagulation tests DIAGNOSTIC_TEST

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

Also known as: Cicatrization tests

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Related Publications (15)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Burns; Hemostatic Disorders; Factor XIII Deficiency; Cicatrix; Thrombosis

Interventions

Blood Coagulation Tests

Condition Hierarchy (Ancestors)

Wounds and Injuries; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Coagulation Protein Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Patricia Guilabert, MD

  Vall d'Hebron Universitary Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Guilabert, MD

CONTACT

0034934 89 30 00; patricia.guilabert@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 16, 2017
• Study Start: June 19, 2017
• Primary Completion: June 19, 2019
• Study Completion: July 21, 2019
• Last Updated: June 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share