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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Factor XIII | Blood Coagulation Factor XIII levels | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Prothrombin Time (PT) | Prothrombin Time blood levels | 30 days |
| Activated Partial Thromboplastin Time (APTT) | Activated Partial Thromboplastin Time blood levels |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Guilabert, MD | Contact | 0034934 89 30 00 | 3504 | patricia.guilabert@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Patricia Guilabert, MD | Vall d'Hebron Universitary Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27543523 | Background | 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. | |
| 26854881 | 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. |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D020141 | Hemostatic Disorders |
| D005177 | Factor XIII Deficiency |
| D002921 | Cicatrix |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D001780 | Blood Coagulation Tests |
| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood
| 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 |
| 24996247 | 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. |
| 23498713 | 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. |
| 20689402 | 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. |
| 22677221 | 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. |
| 18193192 | 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. |
| 16879922 | 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. |
| 15774294 | 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. |
| 11525850 | 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. |
| 20236770 | 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. |
| 22113102 | 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. |
| 15281516 | 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. |
| 16953290 | 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. |
| 19762725 | 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. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D020147 | Coagulation Protein Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D008919 | Investigative Techniques |