Assessment of the Impact of TIP Score on Thromboprophylaxis in Patients With Non-surgical Lower Leg Trauma.

Pulmonary Embolism Clinical Trial

— EvaTIP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03089255
• Other study ID #: 2017-A00291-52
• Status: Completed
• Start date: April 3, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: June 2018
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Embolism
• Leg Injuries
• Lower Limb Injury
• Pulmonary Embolism
• Thrombosis
• Venous Thromboses
• Venous Thrombosis

Locations

Country	Name	City	State
France	Douillet	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

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