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

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ClinicalTrials.gov Identifier: NCT03259204
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : October 7, 2021
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Danderyd Hospital
Stockholm South General Hospital
Uppsala University Hospital
University Hospital, Linkoeping
Visby lasarett
Region Örebro County
Gävle Hospital
Höglandssjukhuset Eksjö
Norrtälje Hospital
Östersunds Hospital
Helsingborgs Hospital
Karlstad Central Hospital
Skövde Hospital
Uddevalla Hospital
Information provided by (Responsible Party):
Paul Ackermann, Karolinska University Hospital

Tracking Information
First Submitted Date  ICMJE August 16, 2017
First Posted Date  ICMJE August 23, 2017
Last Update Posted Date October 7, 2021
Actual Study Start Date  ICMJE September 1, 2018
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2018)
Venous Thromboembolic Events (VTE) [ Time Frame: Up til the time of removal of leg immobilization, approx. 6-8 weeks ]
The primary outcome is VTE defined as symptomatic Deep venous Thrombosis (DVT) or asymptomatic DVTs,or symptomatic pulmonary embolism
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
Venous Thromboembolic Events (VTE) [ Time Frame: 6 weeks ]
The primary outcome is VTE defined as symptomatic Deep venous Thrombosis (DVT) or asymptomatic DVTs,or symptomatic pulmonary embolism
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2021)
  • Patient reported Outcome - ATRS [ Time Frame: 6 months and 1 year ]
    symptoms will be assessed using the reliable and valid score; the Achilles tendon Total Rupture Score (ATRS)
  • Patient reported Outcome - FAOS [ Time Frame: 6 months and 1 year ]
    symptoms will be assessed using the reliable and valid score; the Foot and Ankle Outcome Score (FAOS)
  • Patient reported Outcome - OMAS [ Time Frame: 6 months and 1 year ]
    symptoms will be assessed using the reliable and valid score; the Olerud-Molander Ankle Score (OMAS)
  • Patient reported Outcome - EQ-5D-5L [ Time Frame: 6 months and 1 year ]
    symptoms will be assessed using the reliable and valid score; EuroQol Group's questionnaire (EQ-5D-5L).
  • Functional outcome - muscular endurance tests (heel-rise) [ Time Frame: 1 year ]
    Patient leg function will be measured by a validated endurance test (i.e. the heel-rise test) at 1 year post-injury.
  • Callus production [ Time Frame: 6 weeks ]
    Microdialysis followed by quantification of procollagens will assess callus production in Achilles tendon healing.
  • VTE-preventive mechanisms [ Time Frame: 6 weeks ]
    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 [ Time Frame: 6-8 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
  • Patient reported Outcome - ATRS [ Time Frame: 6 months and 1 year ]
    symptoms will be assessed using the reliable and valid score; the Achilles tendon Total Rupture Score (ATRS)
  • Patient reported Outcome - FAOS [ Time Frame: 6 months and 1 year ]
    symptoms will be assessed using the reliable and valid score; the Foot and Ankle Outcome Score (FAOS)
  • Patient reported Outcome - OMAS [ Time Frame: 6 months and 1 year ]
    symptoms will be assessed using the reliable and valid score; the Olerud-Molander Ankle Score (OMAS)
  • Patient reported Outcome - EQ-5D-5L [ Time Frame: 6 months and 1 year ]
    symptoms will be assessed using the reliable and valid score; EuroQol Group's questionnaire (EQ-5D-5L).
  • Functional outcome - muscular endurance tests (heel-rise) [ Time Frame: 1 year ]
    Patient leg function will be measuerd by a validated enducance test (i.e. the heel-rise test) at 1 year post-injury.
  • Callus production [ Time Frame: 6 weeks ]
    Microdialysis followed by quantification of procollagens will assess callus production in Achilles tendon healing.
  • Fracture union [ Time Frame: 12 weeks ]
    The rate of fracture union (binary), defined as complete callus formation with disappearance of the fracture line in all 3 radiographic views (standard anteroposterior, lateral, and mortise views), will be assessed by x-rays at 12 weeks.
  • VTE-preventive mechanisms [ Time Frame: 6 weeks ]
    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 .
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Swedish Multicenter Trial of Outpatient Prevention of Leg Clots
Official Title  ICMJE Prevention of Thromboembolism and Failed Healing During Lower Limb Immobilization - Multicenter Study With Adjuvant Intermittent Pneumatic Compression Therapy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Achilles Tendon Rupture
  • Ankle Fractures
  • Venous Thromboembolism
Intervention  ICMJE 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.
Study Arms  ICMJE
  • No Intervention: Leg Immobilization
    Routine care include that the lower limb will be immobilized in an orthosis or a below-knee plaster cast according to local routines.
  • Experimental: Adjuvant IPC
    Leg Immobilization with the addition of IPC. Patients will during lower limb immobilization receive bilateral calf IPC.
    Intervention: Device: Adjuvant IPC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2018)
1400
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2017)
1300
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Luigi Belcastro, RN +46851775678 luigi.belcastro@sll.se
Contact: Simon Svedman, MD Simon.svedman@ki.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03259204
Other Study ID Numbers  ICMJE 2017-00202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Paul Ackermann, Karolinska University Hospital
Study Sponsor  ICMJE Karolinska University Hospital
Collaborators  ICMJE
  • Sahlgrenska University Hospital, Sweden
  • Danderyd Hospital
  • Stockholm South General Hospital
  • Uppsala University Hospital
  • University Hospital, Linkoeping
  • Visby lasarett
  • Region Örebro County
  • Gävle Hospital
  • Höglandssjukhuset Eksjö
  • Norrtälje Hospital
  • Östersunds Hospital
  • Helsingborgs Hospital
  • Karlstad Central Hospital
  • Skövde Hospital
  • Uddevalla Hospital
Investigators  ICMJE
Principal Investigator: Paul W Ackermann, MD, PhD Karolinska University Hospital, 171 76 Stockholm, SWEDEN
PRS Account Karolinska University Hospital
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP