Swedish Multicenter Trial of Outpatient Prevention of Leg Clots

Venous Thromboembolism Clinical Trial

— StopLegClots  

Official title:

Prevention of Thromboembolism and Failed Healing During Lower Limb Immobilization - Multicenter Study With Adjuvant Intermittent Pneumatic Compression Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03259204
• Other study ID #: 2017-00202
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Karolinska University Hospital
• Contact: Luigi Belcastro, RN
• Phone: +46724641144
• Email: luigi.belcastro[@]sll.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The proposed intervention, intermittent pneumatic compression (IPC) is an evidence-based prevention for VTE in hospitalized patients and used in daily practice. IPC is, however, not currently used on outpatients and it is currently unknown if it reduces the risk of VTE during long term leg-immobilization. Plaster cast and orthosis treatments are currently used in daily practice on Achilles tendon ruptures and ankle fractures. At present there is no consensus about using VTE prophylaxis in leg-immobilized patients. Since pharmacoprophylaxis has shown low- or no VTE preventive effects in leg-immobilization, is not recommended by some guidelines.

Furthermore, since all patients will undergo clinical examinations and have DVT-screening performed with compression Doppler ultrasound (CDU) removal of leg immobilization this will comprise an extra security for the included patients to detect a VTE. If a VTE is detected clinical guidelines will be followed by initiating chemical VTE-treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Acute unilateral Achilles tendon rupture or isolated Ankle Fracture

• Treatment starts within 10 days in a hospital setting

Exclusion Criteria:

• Inability or refusal to give informed consent for participation in the study

• Inability to comply with the study instructions

• Known kidney disorder

• Heart failure with pitting oedema

• Presence of known malignancy

• Current bleeding disorder

• Pregnancy

• Planned follow-up at another hospital

• Pilon fracture

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Ankle Fractures
• Rupture
• Thromboembolism
• Venous Thromboembolism

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (16)

Lead Sponsor	Collaborator
Karolinska University Hospital	Alingsås Lasarett, Danderyd Hospital, Gävle Hospital, Helsingborgs Hospital, Höglandssjukhuset Eksjö, Istituto Ortopedico Rizzoli, Lugano Regional Hospital, Norra Älvsborgs Länssjukhus, Norrtälje Hospital, Östersund Hospital, Sahlgrenska University Hospital, Sweden, Stockholm South General Hospital, Uddevalla Hospital, University Hospital, Akershus, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Abdul Alim M, Domeij-Arverud E, Nilsson G, Edman G, Ackermann PW. Achilles tendon rupture healing is enhanced by intermittent pneumatic compression upregulating collagen type I synthesis. Knee Surg Sports Traumatol Arthrosc. 2018 Jul;26(7):2021-2029. doi: 10.1007/s00167-017-4621-8. Epub 2017 Jul 1. — View Citation

Arverud ED, Anundsson P, Hardell E, Barreng G, Edman G, Latifi A, Labruto F, Ackermann PW. Ageing, deep vein thrombosis and male gender predict poor outcome after acute Achilles tendon rupture. Bone Joint J. 2016 Dec;98-B(12):1635-1641. doi: 10.1302/0301-620X.98B12.BJJ-2016-0008.R1. — View Citation

Domeij-Arverud E, Ackermann PW. Deep Venous Thrombosis and Tendon Healing. Adv Exp Med Biol. 2016;920:221-8. doi: 10.1007/978-3-319-33943-6_21. — View Citation

Domeij-Arverud E, Labruto F, Latifi A, Nilsson G, Edman G, Ackermann PW. Intermittent pneumatic compression reduces the risk of deep vein thrombosis during post-operative lower limb immobilisation: a prospective randomised trial of acute ruptures of the Achilles tendon. Bone Joint J. 2015 May;97-B(5):675-80. doi: 10.1302/0301-620X.97B5.34581. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous Thromboembolic Events (VTE)	The primary outcome is VTE defined as symptomatic Deep venous Thrombosis (DVT) or asymptomatic DVTs,or symptomatic pulmonary embolism	Up til the time of removal of leg immobilization, approx. 6-8 weeks
Secondary	Patient reported Outcome - ATRS	symptoms will be assessed using the reliable and valid score; the Achilles tendon Total Rupture Score (ATRS)	6 months and 1 year
Secondary	Patient reported Outcome - FAOS	symptoms will be assessed using the reliable and valid score; the Foot and Ankle Outcome Score (FAOS)	6 months and 1 year
Secondary	Patient reported Outcome - OMAS	symptoms will be assessed using the reliable and valid score; the Olerud-Molander Ankle Score (OMAS)	6 months and 1 year
Secondary	Patient reported Outcome - EQ-5D-5L	symptoms will be assessed using the reliable and valid score; EuroQol Group's questionnaire (EQ-5D-5L).	6 months and 1 year
Secondary	Functional outcome - muscular endurance tests (heel-rise)	Patient leg function will be measured by a validated endurance test (i.e. the heel-rise test) at 1 year post-injury.	1 year
Secondary	Callus production	Microdialysis followed by quantification of procollagens will assess callus production in Achilles tendon healing.	6 weeks
Secondary	VTE-preventive mechanisms	VTE-preventive mechanisms will be analyzed at the 6 week visit by assessments of profibrinolysis and coagulation factors as well as by blood-flow quantification .	6 weeks
Secondary	Incidence of VTE in patients using low molecular weight heparin(LMWH) with or without adjvant IPC	Efficacy of LMWH with and without the use of IPC as to prevent VTE will be studied in order to confirm the efficency of a commonly used drug for VTE prophylaxis.	6-8 weeks
Secondary	Patient mortality	Mortality of patients included will be recorded and investigated for cause of death. If the cause of death is VTE, this will be reported. The overall mortality rate in this study is expected to be low. Mortality will be investigated via patient journals at one year after study inclusion, and at 2 years via national mortality register.	1year and 2 years
Secondary	Health economic analyses	Together with Karolinska Institutet, LIME, the trial treatment effects will involve a within-trial evaluation of cost effectiveness integrated into a decision-analytic model of longer run costs and health effects	2 years

External Links

•   Official study site