Pulmonary Embolism Clinical Trial
— EvaTIPOfficial 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.
Verified date | June 2018 |
Source | University Hospital, Angers |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 196 |
Est. completion date | January 30, 2018 |
Est. primary completion date | January 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Douillet | Angers |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
one day | |
Secondary | 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. |
one day | |
Secondary | 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. |
3 months | |
Secondary | 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. |
3 months |
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