search
Back to results

Swedish Multicenter Trial of Outpatient Prevention of Leg Clots (StopLegClots)

Primary Purpose

Achilles Tendon Rupture, Ankle Fractures, Venous Thromboembolism

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Adjuvant IPC
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Achilles Tendon Rupture focused on measuring Achilles tendon, Microdialysis, Immobilization, Wound healing, Intermittent Pneumatic Compression, Ultrasonography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Leg Immobilization

Adjuvant IPC

Arm Description

Routine care include that the lower limb will be immobilized in an orthosis or a below-knee plaster cast according to local routines.

Leg Immobilization with the addition of IPC. Patients will during lower limb immobilization receive bilateral calf IPC.

Outcomes

Primary Outcome Measures

Venous Thromboembolic Events (VTE)
The primary outcome is VTE defined as symptomatic Deep venous Thrombosis (DVT) or asymptomatic DVTs,or symptomatic pulmonary embolism

Secondary Outcome Measures

Patient reported Outcome - ATRS
symptoms will be assessed using the reliable and valid score; the Achilles tendon Total Rupture Score (ATRS)
Patient reported Outcome - FAOS
symptoms will be assessed using the reliable and valid score; the Foot and Ankle Outcome Score (FAOS)
Patient reported Outcome - OMAS
symptoms will be assessed using the reliable and valid score; the Olerud-Molander Ankle Score (OMAS)
Patient reported Outcome - EQ-5D-5L
symptoms will be assessed using the reliable and valid score; EuroQol Group's questionnaire (EQ-5D-5L).
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.
Callus production
Microdialysis followed by quantification of procollagens will assess callus production in Achilles tendon healing.
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 .
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.
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.
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

Full Information

First Posted
August 16, 2017
Last Updated
January 3, 2023
Sponsor
Karolinska University Hospital
Collaborators
Sahlgrenska University Hospital, Sweden, Danderyd Hospital, Stockholm South General Hospital, Uppsala University Hospital, Gävle Hospital, Höglandssjukhuset Eksjö, Norrtälje Hospital, Östersund Hospital, Helsingborgs Hospital, Uddevalla Hospital, Norra Älvsborgs Länssjukhus, Istituto Ortopedico Rizzoli, Lugano Regional Hospital, Alingsås Lasarett, University Hospital, Akershus
search

1. Study Identification

Unique Protocol Identification Number
NCT03259204
Brief Title
Swedish Multicenter Trial of Outpatient Prevention of Leg Clots
Acronym
StopLegClots
Official Title
Prevention of Thromboembolism and Failed Healing During Lower Limb Immobilization - Multicenter Study With Adjuvant Intermittent Pneumatic Compression Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Sahlgrenska University Hospital, Sweden, Danderyd Hospital, Stockholm South General Hospital, Uppsala University Hospital, Gävle Hospital, Höglandssjukhuset Eksjö, Norrtälje Hospital, Östersund Hospital, Helsingborgs Hospital, Uddevalla Hospital, Norra Älvsborgs Länssjukhus, Istituto Ortopedico Rizzoli, Lugano Regional Hospital, Alingsås Lasarett, University Hospital, Akershus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture, Ankle Fractures, Venous Thromboembolism
Keywords
Achilles tendon, Microdialysis, Immobilization, Wound healing, Intermittent Pneumatic Compression, Ultrasonography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Leg Immobilization
Arm Type
No Intervention
Arm Description
Routine care include that the lower limb will be immobilized in an orthosis or a below-knee plaster cast according to local routines.
Arm Title
Adjuvant IPC
Arm Type
Experimental
Arm Description
Leg Immobilization with the addition of IPC. Patients will during lower limb immobilization receive bilateral calf IPC.
Intervention Type
Device
Intervention Name(s)
Adjuvant IPC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Venous Thromboembolic Events (VTE)
Description
The primary outcome is VTE defined as symptomatic Deep venous Thrombosis (DVT) or asymptomatic DVTs,or symptomatic pulmonary embolism
Time Frame
Up til the time of removal of leg immobilization, approx. 6-8 weeks
Secondary Outcome Measure Information:
Title
Patient reported Outcome - ATRS
Description
symptoms will be assessed using the reliable and valid score; the Achilles tendon Total Rupture Score (ATRS)
Time Frame
6 months and 1 year
Title
Patient reported Outcome - FAOS
Description
symptoms will be assessed using the reliable and valid score; the Foot and Ankle Outcome Score (FAOS)
Time Frame
6 months and 1 year
Title
Patient reported Outcome - OMAS
Description
symptoms will be assessed using the reliable and valid score; the Olerud-Molander Ankle Score (OMAS)
Time Frame
6 months and 1 year
Title
Patient reported Outcome - EQ-5D-5L
Description
symptoms will be assessed using the reliable and valid score; EuroQol Group's questionnaire (EQ-5D-5L).
Time Frame
6 months and 1 year
Title
Functional outcome - muscular endurance tests (heel-rise)
Description
Patient leg function will be measured by a validated endurance test (i.e. the heel-rise test) at 1 year post-injury.
Time Frame
1 year
Title
Callus production
Description
Microdialysis followed by quantification of procollagens will assess callus production in Achilles tendon healing.
Time Frame
6 weeks
Title
VTE-preventive mechanisms
Description
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 .
Time Frame
6 weeks
Title
Incidence of VTE in patients using low molecular weight heparin(LMWH) with or without adjvant IPC
Description
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.
Time Frame
6-8 weeks
Title
Patient mortality
Description
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.
Time Frame
1year and 2 years
Title
Health economic analyses
Description
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
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Belcastro, RN
Phone
+46724641144
Email
luigi.belcastro@sll.se
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Svedman, MD
Email
Simon.svedman@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul W Ackermann, MD, PhD
Organizational Affiliation
Karolinska University Hospital, 171 76 Stockholm, SWEDEN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Svedman, MD
Email
Simon.svedman@ki.se
First Name & Middle Initial & Last Name & Degree
Luigi Belcastro, RN
Phone
+46724641144
Email
luigi.belcastro@sll.se

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27909125
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.
Results Reference
background
PubMed Identifier
27535264
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.
Results Reference
background
PubMed Identifier
25922463
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.
Results Reference
background
PubMed Identifier
28668970
Citation
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.
Results Reference
background
PubMed Identifier
34016662
Citation
Svedman S, Alkner B, Berg HE, Domeij-Arverud E, Jonsson K, Nilsson Helander K, Ackermann PW. STOP leg clots-Swedish multicentre trial of outpatient prevention of leg clots: study protocol for a randomised controlled trial on the efficacy of intermittent pneumatic compression on venous thromboembolism in lower leg immobilised patients. BMJ Open. 2021 May 20;11(5):e044103. doi: 10.1136/bmjopen-2020-044103.
Results Reference
derived
Links:
URL
http://ki.se/mmk/stop-leg-clots
Description
Official study site

Learn more about this trial

Swedish Multicenter Trial of Outpatient Prevention of Leg Clots

We'll reach out to this number within 24 hrs