Factor XIII in Major Burns Coagulation

Major Burns Coagulation and the Role of Factor XIII: A Descriptive Study

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

Study Overview

• Status: Unknown
• Conditions: Burns; Coagulation Disorder; Endothelial Dysfunction; Factor XIII Deficiency; Cicatrization
• Intervention / Treatment: Diagnostic test: Coagulation tests

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factor XIII	Blood Coagulation Factor XIII levels	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Investigators: Principal Investigator: Patricia Guilabert, MD, Vall d'Hebron Universitary Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 19, 2017
• Primary Completion (Anticipated): June 19, 2019
• Study Completion (Anticipated): July 21, 2019

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Burns; Factor XIII; Coagulation; Glycocalix; Cicatrization
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries; Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Fibrosis; Burns; Hemostatic Disorders; Blood Coagulation Disorders; Cicatrix; Factor XIII Deficiency
• Other Study ID Numbers: PR(ATR)341/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No