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

NCT ID: NCT03089255

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 196 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-03
• Study Completion Date: 2018-01-30

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roy Pierre-Marie, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

Douillet

Angers, , France

Countries

France

Other Identifiers

2017-A00291-52

Identifier Type: -

Identifier Source: org_study_id