Skin Burn ExtensiveNCT01421537
Evaluation Of Enoxaparin Pharmacokinetic For Thromboprophylaxis In Burn Care Patients
An observational study of Skin Burn Extensive, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
OVERVIEW: Thromboembolisms represent a serious and feared complication in hospitalized patients. Several factors make the ICU patient population at increased risk of venous thromboembolism. A high incidence of thromboembolic events is starting to emerge from recent medical literature in the burn patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Burn Extensive
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Jan 2013
- 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: Hospitalized patients in : * general medical ward * mixte intensive care unit * burn patient intensive care unit
Who may be able to join
- Patients age 18 and over
- Burn injuries greater than 20%
- Received at least 24 hours of enoxaparin prior to the sampling series
- Patients admitted to Hôtel-Dieu hospital of the "CHUM: Centre hospitalier de l'Université de Montréal"
Who cannot join
- Age less than 18 years
- Pregnancy
- Patients in the postoperative period (within 24 hours of the surgery)
- Patients with a contraindication for heparin use (Heparin induced thrombocytopenia and severe hemorrhage)
- Patients needing therapeutic anticoagulation
- Hepatic insufficiency prior to the burn injury (CHILD-PUGH B or more)
Show all 9Show fewer
- Patients with a hemoglobin inferior to 70g/L
- Patients with a renal clearance less than 30 ml/min as calculated with the Cockroff-Gault formula prior to the burn care admission.
- Patients without basic French or English comprehension.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2W 1T8
About this study
OVERVIEW:
- Thromboembolisms represent a serious and feared complication in hospitalized patients.
- Several factors make the ICU patient population at increased risk of venous thromboembolism.
- A high incidence of thromboembolic events is starting to emerge from recent medical literature in the burn patient.
- Actual guidelines for thromboprophylaxis in burn care patients are based on multiple non-burn patient trials.
- Burn patient physiology is radically different than that of general ward hospitalized patients
- Since the actual chemical thromboprophylaxis have not been evaluated in the burn patient, it is of interest to assess their efficacy in patients with severe burns.
- Hence, the pharmacokinetic characterization of heparins (a well accepted mode of thromboprophylaxis) in burn patients could guide future quality of care for this subclass of patients.
Read more
Our proposal is based on the conviction that anti-Xa activity of low-molecular-weight heparins in the burn patients do not correlate with levels described to prevent thromboembolic events in the general hospitalized population.
The investigators aim to:
- To evaluate pharmacokinetics and pharmacodynamics of low-molecular-weight heparins (enoxaparin), with anti-Xa levels in severely burned patients receiving thromboprophylaxis.
- To determine the correlation between antithrombotic activity of heparins and the different metabolic phases of the thermally injured patient.
Read the detailed description
Deep venous thrombosis (DVT) has taken a prevalent place in medical literature over the past decades. In an attempt to decrease its impact on hospitalized patients, multiple trials have tried to better define its frequency and consequences on a very broad range of patients. The differences between these sub populations of ill individuals influence greatly the occurrence of venous thrombotic events (VTE).
Critically ill patients are predisposed to VTEs. The nature of the disease may have an important impact on the risk for DVT. Mechanical ventilation, central line placement, surgery, vasopressors and immobilization are some of the realities of ICU patients. They contribute to the enhanced chance for thromboembolic complications in this population, either by venous stasis (immobilization), endothelial injury (surgery…) or hypercoagulability. Trauma patients represent a subclass of critical care patients with a high incidence of DVT. It has been evaluated as high as 44,1% even in patients with thrombotic prophylaxis with low-dose unfractioned heparin.
Burn patient are also at increased risk of deep vein thrombosis and pulmonary embolisms. Recent prospective trials in burn patients have described an incidence of thromboembolic complications in the range of 6 to 60%. Autopsy evaluations are also in favor of an elevated incidence of thrombotic events in thermally injured patients(37 to 60%).
At the present time, no trial has evaluated the efficacy of the pharmacologic methods used for thromboprophylaxis in burned patients. Comparative efficacy between different patient populations (including thermally injured patients) has never been undertook. Thus, the investigators have to question the adequacy of present thromboprophylactic measures in burn patients? Are the actual method of DVT and PE prophylaxis sufficient in severe burns?
The physiology of moderate to severe burns makes us believe it is not. In the early post burn period, a massive fluid reanimation is initiated. The Starling forces are destabilized in favor of an increased capillary leak to the interstitial space. The net effect is the increase in free water in the interstitium and formation of important edema. The distance between the epithelium and the vascular space is then potentially increased. Furthermore, the central intravascular compartment of such individuals becomes very difficult to access. This leads us to reconsider the efficiency of the subcutaneous route. In cases of severe accumulation of interstitial fluid, can the subcutaneous administration of medications lead to the desired therapeutic effect?
The investigators plan to compare the levels of anti-Xa levels between 3 patient populations: severely burned patients (> 20%), medical ICU patients and general medical ward patients.
- Conditions
- Skin Burn Extensive
- Keywords
- Thromboprophylaxis, enoxaparin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Burn ExtensiveStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Lafrance, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)Anita Ang, M. Sc, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)Nicholas Robillard, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)Mikhael Laskine, MD, Principal investigator, CHUMNormand Blais, MD, Principal investigator, CHUMSylvain Belisle, MD, Principal investigator, CHUMMarc-Jacques Dubois, MD, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421537
- Sponsor's protocol ID
- CE 10.148
- Status last verified
- Jul 2020
- First submitted
- 19 Aug 2011
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Enoxaparin Pharmacokinetic For Thromboprophylaxis In Burn Care Patients
- ClinicalTrials.gov ID
- NCT01421537
- Acronym / sponsor ID
- CE 10.148
- Conditions
- Skin Burn Extensive
- Keywords
- Thromboprophylaxis, enoxaparin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 Aug 2011 (estimated)
- 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.
OVERVIEW:
- Thromboembolisms represent a serious and feared complication in hospitalized patients.
- Several factors make the ICU patient population at increased risk of venous thromboembolism.
- A high incidence of thromboembolic events is starting to emerge from recent medical literature in the burn patient.
- Actual guidelines for thromboprophylaxis in burn care patients are based on multiple non-burn patient trials.
- Burn patient physiology is radically different than that of general ward hospitalized patients
- Since the actual chemical thromboprophylaxis have not been evaluated in the burn patient, it is of interest to assess their efficacy in patients with severe burns.
- Hence, the pharmacokinetic characterization of heparins (a well accepted mode of thromboprophylaxis) in burn patients could guide future quality of care for this subclass of patients.
Our proposal is based on the conviction that anti-Xa activity of low-molecular-weight heparins in the burn patients do not correlate with levels described to prevent thromboembolic events in the general hospitalized population.
The investigators aim to:
- To evaluate pharmacokinetics and pharmacodynamics of low-molecular-weight heparins (enoxaparin), with anti-Xa levels in severely burned patients receiving thromboprophylaxis.
- To determine the correlation between antithrombotic activity of heparins and the different metabolic phases of the thermally injured patient.
Detailed description
Deep venous thrombosis (DVT) has taken a prevalent place in medical literature over the past decades. In an attempt to decrease its impact on hospitalized patients, multiple trials have tried to better define its frequency and consequences on a very broad range of patients. The differences between these sub populations of ill individuals influence greatly the occurrence of venous thrombotic events (VTE).
Critically ill patients are predisposed to VTEs. The nature of the disease may have an important impact on the risk for DVT. Mechanical ventilation, central line placement, surgery, vasopressors and immobilization are some of the realities of ICU patients. They contribute to the enhanced chance for thromboembolic complications in this population, either by venous stasis (immobilization), endothelial injury (surgery…) or hypercoagulability. Trauma patients represent a subclass of critical care patients with a high incidence of DVT. It has been evaluated as high as 44,1% even in patients with thrombotic prophylaxis with low-dose unfractioned heparin.
Burn patient are also at increased risk of deep vein thrombosis and pulmonary embolisms. Recent prospective trials in burn patients have described an incidence of thromboembolic complications in the range of 6 to 60%. Autopsy evaluations are also in favor of an elevated incidence of thrombotic events in thermally injured patients(37 to 60%).
At the present time, no trial has evaluated the efficacy of the pharmacologic methods used for thromboprophylaxis in burned patients. Comparative efficacy between different patient populations (including thermally injured patients) has never been undertook. Thus, the investigators have to question the adequacy of present thromboprophylactic measures in burn patients? Are the actual method of DVT and PE prophylaxis sufficient in severe burns?
The physiology of moderate to severe burns makes us believe it is not. In the early post burn period, a massive fluid reanimation is initiated. The Starling forces are destabilized in favor of an increased capillary leak to the interstitial space. The net effect is the increase in free water in the interstitium and formation of important edema. The distance between the epithelium and the vascular space is then potentially increased. Furthermore, the central intravascular compartment of such individuals becomes very difficult to access. This leads us to reconsider the efficiency of the subcutaneous route. In cases of severe accumulation of interstitial fluid, can the subcutaneous administration of medications lead to the desired therapeutic effect?
The investigators plan to compare the levels of anti-Xa levels between 3 patient populations: severely burned patients (> 20%), medical ICU patients and general medical ward patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients in : * general medical ward * mixte intensive care unit * burn patient intensive care unit
Key inclusion criteria (4 listed)
- Patients age 18 and over
- Burn injuries greater than 20%
- Received at least 24 hours of enoxaparin prior to the sampling series
- Patients admitted to Hôtel-Dieu hospital of the "CHUM: Centre hospitalier de l'Université de Montréal"
Key exclusion criteria (9 listed)
- Age less than 18 years
- Pregnancy
- Patients in the postoperative period (within 24 hours of the surgery)
- Patients with a contraindication for heparin use (Heparin induced thrombocytopenia and severe hemorrhage)
- Patients needing therapeutic anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
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.
Dominique Lafrance, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Anita Ang, M. Sc principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Nicholas Robillard, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Burn Extensive, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 3 Aug 2020.