Factor XIII in Major Burns Coagulation

NCT ID: NCT03188913

Last Updated: 2017-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-19

Study Completion Date

2019-07-21

Brief Summary

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

Detailed Description

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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.

Conditions

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Burns Coagulation Disorder Factor XIII Deficiency Cicatrization Endothelial Dysfunction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Cicatrization tests

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia Guilabert, MD

Role: PRINCIPAL_INVESTIGATOR

Vall d'Hebron Universitary Hospital

Central Contacts

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Patricia Guilabert, MD

Role: CONTACT

0034934 89 30 00 ext. 3504

References

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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.

Reference Type BACKGROUND
PMID: 27543523 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26854881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24996247 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23498713 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20689402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22677221 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18193192 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16879922 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15774294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11525850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20236770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22113102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15281516 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 16953290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19762725 (View on PubMed)

Other Identifiers

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PR(ATR)341/2016

Identifier Type: -

Identifier Source: org_study_id

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