BurnsNCT03188913
Factor XIII in Major Burns Coagulation
An observational study of Burns and Coagulation Disorder, run by Hospital Universitari Vall d'Hebron Research Institute.
Trial summary
Prospective observational study in which FXIII levels and coagulation tests and cicatrization are measured during the 30 days after the thermal trauma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Coagulation Disorder, Factor XIII Deficiency
- What is being tested?
- Coagulation tests
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 19 Jun 2017to 21 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Burned patients with a burned body surface of 20% or more
- Over 18 years of age
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Burns, Coagulation Disorder, Factor XIII Deficiency, Cicatrization, Endothelial Dysfunction
- Being tested
- Coagulation tests
- Keywords
- Burns, Coagulation, Factor XIII, Glycocalix, Cicatrization
- Medical subject headings
- Burns, Hemostatic Disorders, Factor XIII Deficiency, Cicatrix, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coagulation testsDiagnostic test
Also called Cicatrization 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Factor XIII
Blood Coagulation Factor XIII levels
Measured: 30 days
Secondary outcomes (24)
Prothrombin Time (PT)
Prothrombin Time blood levels
Measured: 30 days
Activated Partial Thromboplastin Time (APTT)
Activated Partial Thromboplastin Time blood levels
Measured: 30 days
Thrombin Time (TT)
Thrombin Time blood levels
Measured: 30 days
Fibrinogen
Functional fibrinogen blood levels
Measured: 30 days
Lactate
Lactate blood levels
Measured: 30 days
Base Excess (BE)
Base Excess blood levels
Measured: 30 days
Fibrin monomers
Fibrin monomers blood levels
Measured: 30 days
Factor XII
Factor XII blood levels
Measured: 30 days
Factor VIII
Factor VIII blood levels
Measured: 30 days
Factor von Willebrand
Factor von Willebrand blood levels
Measured: 30 days
Plasmin
Plasmin blood levels
Measured: 30 days
Plasminogen
Plasminogen blood levels
Measured: 30 days
Alpha-2-antiplasmin
Alpha-2-antiplasmin blood levels
Measured: 30 days
Antithrombin (AT)
Antithrombin blood levels
Measured: 30 days
Protein C
Protein C blood levels
Measured: 30 days
Heparan sulfate
Heparan sulfate blood levels
Measured: 30 days
Syndecan 1
Syndecan 1 blood levels
Measured: 30 days
Healing Vancouver test
The Vancouver survey will be conducted on the state of healing
Measured: 30 days
Healing POSAS test
The POSAS survey will be conducted on the state of healing
Measured: 30 days
Tewamether moisture titration
Tewamether consists of two pairs of sensors to measure the humidity and temperature gradients in two different spacings
Measured: 30 days
Surgical bleeding survey
A surgical team survey will be performed on intraoperative bleeding (during the first debridal surgery)
Measured: 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
Measured: 11 days
Surface debrided
The percentage of debrided surface and type of debridement (in the first debriding surgery)
Measured: 10 days
Surgery Bleeding
Estimated bleeding according to the modified Gross formula (in the first debriding surgery)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start19 Jun 2017 (estimated)
- Primary completion19 Jun 2019 (estimated)
- Study completion21 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Guilabert, MD, Principal investigator, Vall d'Hebron Universitary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188913
- Sponsor's protocol ID
- PR(ATR)341/2016
- Status last verified
- May 2017
- First submitted
- 31 May 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27543523Glas 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.
PubMed 26854881Sherren 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.
PubMed 24996247Sherren 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.
PubMed 23498713King DR, Namias N, Andrews DM. Coagulation abnormalities following thermal injury. Blood Coagul Fibrinolysis. 2010 Oct;21(7):666-9. doi: 10.1097/MBC.0b013e32833ceb08.
PubMed 20689402Mitra 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.
PubMed 22677221Lavrentieva 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.
PubMed 18193192Barret 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.
PubMed 16879922Barret 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.
PubMed 15774294Aoki 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.
PubMed 11525850Levin 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.
PubMed 20236770Schaden 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.
PubMed 22113102Nielsen 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.
PubMed 15281516Korte W. [Fibrin monomer and factor XIII: a new concept for unexplained intraoperative coagulopathy]. Hamostaseologie. 2006 Aug;26(3 Suppl 1):S30-5. German.
PubMed 16953290Jambor 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.
PubMed 19762725
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Major Burns Coagulation and the Role of Factor XIII: A Descriptive Study
- ClinicalTrials.gov ID
- NCT03188913
- Acronym / sponsor ID
- PR(ATR)341/2016
- Conditions
- Burns, Coagulation Disorder, Factor XIII Deficiency, Cicatrization, Endothelial Dysfunction
- Keywords
- Burns, Coagulation, Factor XIII, Glycocalix, Cicatrization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 19 Jun 2017 (estimated)
- Primary completion
- 19 Jun 2019 (estimated)
- Study completion
- 21 Jul 2019 (estimated)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective observational study in which FXIII levels and coagulation tests and cicatrization are measured during the 30 days after the thermal trauma.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Burned patients with a burned body surface of 20% or more
- Over 18 years of age
Key exclusion criteria (7 listed)
- ABSI (Abbreviated Burns Severity Index) greater than or equal to 12
- Associated polytrauma
- Coagulation deficit previously known
- Treatment with anticoagulants
- Electrocution burns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coagulation testsAlso: Cicatrization testsThe 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 | Diagnostic test | – |
Primary outcome
Factor XIII
Time frame: 30 days
Blood Coagulation Factor XIII levels
24 secondary outcomes
Prothrombin Time (PT)
Time frame: 30 days
Activated Partial Thromboplastin Time (APTT)
Time frame: 30 days
Thrombin Time (TT)
Time frame: 30 days
Fibrinogen
Time frame: 30 days
Lactate
Time frame: 30 days
Base Excess (BE)
Time frame: 30 days
Fibrin monomers
Time frame: 30 days
Factor XII
Time frame: 30 days
Factor VIII
Time frame: 30 days
Factor von Willebrand
Time frame: 30 days
Plasmin
Time frame: 30 days
Plasminogen
Time frame: 30 days
Alpha-2-antiplasmin
Time frame: 30 days
Antithrombin (AT)
Time frame: 30 days
Protein C
Time frame: 30 days
Heparan sulfate
Time frame: 30 days
Syndecan 1
Time frame: 30 days
Healing Vancouver test
Time frame: 30 days
Healing POSAS test
Time frame: 30 days
Tewamether moisture titration
Time frame: 30 days
Surgical bleeding survey
Time frame: 10 days
Reintervention due to bleeding
Time frame: 11 days
Surface debrided
Time frame: 10 days
Surgery Bleeding
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Background: PubMed 27543523Guilabert 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.
- Background: PubMed 26854881Glas 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.
- Background: PubMed 24996247Sherren 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.
- Background: PubMed 23498713Sherren 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.
- Background: PubMed 20689402King DR, Namias N, Andrews DM. Coagulation abnormalities following thermal injury. Blood Coagul Fibrinolysis. 2010 Oct;21(7):666-9. doi: 10.1097/MBC.0b013e32833ceb08.
- Background: PubMed 22677221Mitra 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.
- Background: PubMed 18193192Lavrentieva 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.
- Background: PubMed 16879922Barret 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.
- Background: PubMed 15774294Barret 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.
- Background: PubMed 11525850Aoki 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.
- Background: PubMed 20236770Levin 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.
- Background: PubMed 22113102Schaden 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Guilabert, MD principal investigator
Vall d'Hebron Universitary Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Coagulation Disorder, run by Hospital Universitari Vall d'Hebron Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Guilabert, MD (0034934 89 30 00 ext. 3504, patricia.guilabert@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factor XIII (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188913, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.