Swedish Multicenter Trial of Outpatient Prevention of Leg Clots

Summary

Lower limb immobilization is associated with high risk of complications, i.e. venous thromboembolism (VTE) and failed healing. Pharmacoprophylaxis of VTE is in leg-immobilized patients, however, low- or non-effective and associated with adverse events. Thus, there is a need for novel treatments.

This study aims to demonstrate in leg immobilized patients who have suffered an ankle fracture (1000 patients) or an Achilles tendon rupture (400 patients) that adjuvant intermittent pneumatic compression (IPC) therapy, which targets impaired vascular flow, compared to treatment-as-usual with plaster cast, reduces VTE incidence and improves healing.

Conditions

• Achilles Tendon Rupture
• Ankle Fractures
• Venous Thromboembolism

Interventions

DEVICE

Adjuvant IPC

This IPC-system delivers sequential circumferential compression. The IPC device is mobile and should therefore not restrict patient mobilization, but can be taken off if the patient wants to mobilize independently.

Sponsors & Collaborators

• Sahlgrenska University Hospital

  collaborator OTHER

• Danderyd Hospital

  collaborator OTHER

• Stockholm South General Hospital

  collaborator OTHER

• Uppsala University Hospital

  collaborator OTHER

• Gävle Hospital

  collaborator OTHER

• Höglandssjukhuset Eksjö

  collaborator UNKNOWN

• Norrtälje Hospital

  collaborator UNKNOWN

• Östersund Hospital

  collaborator UNKNOWN

• Helsingborgs Hospital

  collaborator OTHER

• Uddevalla Hospital

  collaborator UNKNOWN

• Norra Älvsborgs Länssjukhus

  collaborator UNKNOWN

• Istituto Ortopedico Rizzoli

  collaborator OTHER

• Lugano Regional Hospital

  collaborator UNKNOWN

• Alingsås Lasarett

  collaborator UNKNOWN

• University Hospital, Akershus

  collaborator OTHER

• Karolinska University Hospital

  lead OTHER

Principal Investigators

• Paul W Ackermann, MD, PhD · Karolinska University Hospital, 171 76 Stockholm, SWEDEN

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-01

Primary Completion

2024-12-31

Completion

2025-12-31

Countries

• Sweden

Study Locations