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

NCT03089255 | Completed DMC

• 1 other identifier: 2017-A00291-52
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Injury; Pulmonary Embolism; Venous Thromboses

Keywords

Thrombophylaxis; Deep Venous Thrombosis; Pulmonary Embolism; Lower Leg Trauma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of prescriptions of prophylactic anticoagulation if L-TRIP(cast) score was applied compared to the physicians' judgment in standard practice.

  one day

• The cumulative rate of symptomatic venous thromboembolism (i.e. deep venous thrombosis and/or pulmonary embolism) at 3 months from inclusion.

  3 months

• The 3-month rate of major bleeding and of non-major clinically relevant bleeding according to the ISTH definition.

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted in the Emergency Department for an isolated lower-leg trauma injury non surgical requiring semi-rigid or rigid immobilisation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Douillet

Angers, 49000, France

Location

MeSH Terms

Conditions

Leg Injuries; Pulmonary Embolism; Venous Thrombosis

Condition Hierarchy (Ancestors)

Wounds and Injuries; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Study Officials

• Roy Pierre-Marie, MD, PhD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 24, 2017
• Study Start: April 3, 2017
• Primary Completion: January 15, 2018
• Study Completion: January 30, 2018
• Last Updated: June 4, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)