Factor XIII in Major Burns Coagulation

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03188913
• Other study ID #: PR(ATR)341/2016
• Status: Not yet recruiting
• Phase: N/A
• First received: May 31, 2017
• Last updated: June 15, 2017
• Start date: June 19, 2017
• Est. completion date: July 21, 2019

Study information

• Verified date: May 2017
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Patricia Guilabert, MD
• Phone: 0034934 89 30 00
• Email: patricia.guilabert[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 21, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Burns
• Cicatrix
• Cicatrization
• Coagulation Disorder
• Endothelial Dysfunction
• Factor XIII Deficiency
• Hemostatic Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

References & Publications (15)

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. — View Citation

Barret JP, Dziewulski PG. Complications of the hypercoagulable status in burn injury. Burns. 2006 Dec;32(8):1005-8. Epub 2006 Aug 1. — View Citation

Barret JP, Gomez PA. Disseminated intravascular coagulation: a rare entity in burn injury. Burns. 2005 May;31(3):354-7. Epub 2005 Jan 21. — View 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. Review. — View Citation

Guilabert P, Usúa G, Martín 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. Review. — View Citation

Jámbor 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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):120-3. — View 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

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