Lower Limb InjuryEvaTIPNCT03089255
Assessment of the Impact of TIP Score on Thromboprophylaxis in Patients With Non-surgical Lower Leg Trauma.
An observational study of Lower Limb Injury and Pulmonary Embolism, run by University Hospital, Angers at 1 site in France.
Trial summary
Traumatic lesions are the leading causes of admission to the emergency center (39%), isolated non-surgical lower limbs trauma are in the foreground. Two recent meta-analyzes suggest the value of Low Molecular Weight Heparins (LMWH) which would reduce symptomatic Thromboembolism Events (TE) in patients with lower limb… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Injury, Pulmonary Embolism, Venous Thromboses
- How many people
- 196 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2017to 30 Jan 2018
- How long will I take part?
- 3 Months
- 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: All patients admitted in the Emergency Department for an isolated lower-leg trauma injury non surgical requiring semi-rigid or rigid immobilisation.
Who may be able to join
- Consultation in one of the emergency departments of the participating centres
- Isolated unilateral lower limb injury not requiring surgery
- Lower limb rigid or semi-rigid orthopedic immobilization (i.e. brace of plaster cast) for at least 5 days.
- Full insurance cover
Who cannot join
- Any anticoagulant or antiplatelet treatment prior to trauma
- Contra-indication to fondaparinux or LMWH
- Factors rendering 3-month follow-up impossible
- Imprisonment
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study to Assess the Foreseeable Impact of TIP Score on Thromboprophylaxis in Patients With Isolated Non-surgical Lower Limb Trauma Compared to the Physicians' Judgment in Standard Practice.
Traumatic lesions are the leading causes of admission to the emergency center (39%), isolated non-surgical lower limbs trauma are in the foreground. Two recent meta-analyzes suggest the value of Low Molecular Weight Heparins (LMWH) which would reduce symptomatic Thromboembolism Events (TE) in patients with lower limb trauma. However, many recent studies conclude to the need of stratifying the TE risk according to the patient and the nature of his trauma to obtain an individualized therapeutic decision.
The retrospectively established L-TRIP (cast) score allows stratification of the risk without taking into account the type of trauma. The TIP score (Trauma, Immobilization and Patient) was established by consensus of international experts via the Delphi method.
We suggest that the application of the TIP score to rationalize indications of thromboprophylaxis in patients with isolated non-surgical trauma of a lower limb should reduce the rate of anticoagulation prescription without increasing the risk of symptomatic thromboembolic complications with a direct benefit for patients and medico-economic for the society.
Read the detailed description
All patients admitted to the Emergency Departments for a nonsurgical isolated lower limb trauma necessitating rigid or semi-rigid immobilization, will be assessed for possible participation.
After the physicians had obtained the no-opposition of the patient, they will fill a questionnaire. This questionnaire includes the treatment chosen by the physician, the type of trauma, the type of immobilization chosen, and the patient's thromboembolic risk factors in order to calculate the TIP and L-TRIP (cast) scores retrospectively.
Phone follow-up will occur within 3 months to gather clinical event data (any signs of VTE, any bleeding events).
- Conditions
- Lower Limb Injury, Pulmonary Embolism, Venous Thromboses
- Keywords
- Thrombophylaxis, Deep Venous Thrombosis, Pulmonary Embolism, Lower Leg Trauma
- Medical subject headings
- Leg Injuries, Pulmonary Embolism, Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of prescriptions of prophylactic anticoagulation if TIP score was applied compared to the physicians' judgment in standard practice.
Compare two rate (percent) of prescription: obtained with standard practice and with the foreseeable TIP score calculated retrospectively.
Score TIP is calculated retrospectively based on datas of the patients included. A threshold value is established by an expert consensus. A score is positive if it is higher than the threshold value, and negative if it is lower or equal to the threshold value. We consider that patients with a negative score would not have been treated by a prophylactic anticoagulation if the TIP score was applied.
Measured: one day
Secondary outcomes (3)
Rate of prescriptions of prophylactic anticoagulation if L-TRIP(cast) score was applied compared to the physicians' judgment in standard practice.
Compare two rate (percent) of prescription: obtained with standard practice and with the foreseeable L-TRIP(cast) score calculated retrospectively.
A score is positive if it is higher than the threshold value, and negative if it is lower or equal to the threshold value. We consider that patients with a negative score would not have been treated by a prophylactic anticoagulation if the TIP score was applied.
Measured: one day
The cumulative rate of symptomatic venous thromboembolism (i.e. deep venous thrombosis and/or pulmonary embolism) at 3 months from inclusion.
The following definitions are applied to confirm a suspected episode of symptomatic :
- DVT: abnormal compression ultrasound
- PE: an intraluminal filling defect in segmental or more proximal branches on spiral CT Scan or a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan or detected at autopsy.
Measured: 3 months
The 3-month rate of major bleeding and of non-major clinically relevant bleeding according to the ISTH definition.
The safety endpoint is major bleeding, defined according to the recently published guidelines of the ISTH :
- Fatal bleed ing, and/or
- Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra- articular or pericardial, or intramuscular with compartment syndrome, and/or
- Bleeding causing a fall in hemoglobin level of 20 g.L (1.24 mmol.L) 1 or more, or leading to transfusion of two or more units of whole blood or red cells.
The cumulative incidence of non-major clinically relevant bleeding. The cumulative incidence of minor bleeding.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start3 Apr 2017
- Primary completion15 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Roy Pierre-Marie, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089255
- Sponsor's protocol ID
- 2017-A00291-52
- Acronym
- EvaTIP
- Status last verified
- Jun 2018
- First submitted
- 17 Mar 2017
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Assess the Foreseeable Impact of TIP Score on Thromboprophylaxis in Patients With Isolated Non-surgical Lower Limb Trauma Compared to the Physicians' Judgment in Standard Practice.
- ClinicalTrials.gov ID
- NCT03089255
- Acronym / sponsor ID
- EvaTIP / 2017-A00291-52
- Conditions
- Lower Limb Injury, Pulmonary Embolism, Venous Thromboses
- Keywords
- Thrombophylaxis, Deep Venous Thrombosis, Pulmonary Embolism, Lower Leg Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 24 Mar 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.
Traumatic lesions are the leading causes of admission to the emergency center (39%), isolated non-surgical lower limbs trauma are in the foreground. Two recent meta-analyzes suggest the value of Low Molecular Weight Heparins (LMWH) which would reduce symptomatic Thromboembolism Events (TE) in patients with lower limb trauma. However, many recent studies conclude to the need of stratifying the TE risk according to the patient and the nature of his trauma to obtain an individualized therapeutic decision.
The retrospectively established L-TRIP (cast) score allows stratification of the risk without taking into account the type of trauma. The TIP score (Trauma, Immobilization and Patient) was established by consensus of international experts via the Delphi method.
We suggest that the application of the TIP score to rationalize indications of thromboprophylaxis in patients with isolated non-surgical trauma of a lower limb should reduce the rate of anticoagulation prescription without increasing the risk of symptomatic thromboembolic complications with a direct benefit for patients and medico-economic for the society.
Detailed description
All patients admitted to the Emergency Departments for a nonsurgical isolated lower limb trauma necessitating rigid or semi-rigid immobilization, will be assessed for possible participation.
After the physicians had obtained the no-opposition of the patient, they will fill a questionnaire. This questionnaire includes the treatment chosen by the physician, the type of trauma, the type of immobilization chosen, and the patient's thromboembolic risk factors in order to calculate the TIP and L-TRIP (cast) scores retrospectively.
Phone follow-up will occur within 3 months to gather clinical event data (any signs of VTE, any bleeding events).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted in the Emergency Department for an isolated lower-leg trauma injury non surgical requiring semi-rigid or rigid immobilisation.
Key inclusion criteria (4 listed)
- Consultation in one of the emergency departments of the participating centres
- Isolated unilateral lower limb injury not requiring surgery
- Lower limb rigid or semi-rigid orthopedic immobilization (i.e. brace of plaster cast) for at least 5 days.
- Full insurance cover
Key exclusion criteria (5 listed)
- Any anticoagulant or antiplatelet treatment prior to trauma
- Contra-indication to fondaparinux or LMWH
- Factors rendering 3-month follow-up impossible
- Imprisonment
- Inability to provide informed consent
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
Rate of prescriptions of prophylactic anticoagulation if TIP score was applied compared to the physicians' judgment in standard practice.
Time frame: one day
Compare two rate (percent) of prescription: obtained with standard practice and with the foreseeable TIP score calculated retrospectively. Score TIP is calculated retrospectively based on datas of the patients included. A threshold value is established by an expert consensus. A score is positive if it is higher than the threshold value, and negative if it is lower or equal to the threshold value. We consider that patients with a negative score would not have been treated by a prophylactic anticoagulation if the TIP score was applied.
3 secondary outcomes
Rate of prescriptions of prophylactic anticoagulation if L-TRIP(cast) score was applied compared to the physicians' judgment in standard practice.
Time frame: one day
The cumulative rate of symptomatic venous thromboembolism (i.e. deep venous thrombosis and/or pulmonary embolism) at 3 months from inclusion.
Time frame: 3 months
The 3-month rate of major bleeding and of non-major clinically relevant bleeding according to the ISTH definition.
Time frame: 3 months
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 4 Jun 2018.
- 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.
Roy Pierre-Marie, MD, PhD principal investigator
University Hospital, Angers
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 Lower Limb Injury and Pulmonary Embolism, run by University Hospital, Angers at 1 site in France.
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 5 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 4 Jun 2018. 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 France. 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.
What does the primary outcome measure?
Rate of prescriptions of prophylactic anticoagulation if TIP score was applied compared to the physicians' judgment in standard practice. (time frame: one day). It is what the study was designed to measure, not a finding.
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 4 Jun 2018.