CLOTS 3 Trial

DIAGRAM depicting Clots 3 trial - see view text alternative for details

  • The CLOTS 3 trial was a large multi-centre randomised trial which recruited patients in 94 UK hospitals
  • The primary outcome was a proximal (above knee) DVT by 30 days
  • Patients were also followed up to identify any DVT, PE for the first 6 months
  • Also to measure survival, disability and quality of life at 6 months

Intermittent pneumatic compression (IPC)

  • A large number of small randomised trials have shown that IPC reduced the risk of DVT in patients undergoing surgery.
  • The CLOTS 3 trial has shown that IPC reduces the risk of DVT in immobile stroke patients.
  • The CLOTS 3 trial also suggested that stroke patients treated with IPC have a greater chance of surviving.
    CLOTS 3 trial results paper
    . CLOTS trial 3 (secondary analyses)
  • SIGN guidelines now recommend that use of IPC should be considered in immobile stroke patients

Graduated compression stockings (GCS)

  • small trials in surgical patients, where stockings can be applied before immobility, have suggested that they reduce the risk of DVT
  • however the large CLOTS 1 trial has conclusively shown that graduated compression stockings do not reduce the risk of DVT after stroke
  • they are difficult to fit, apply and maintain
  • patients find them uncomfortable
  • they cause pressure sores and skins problems in 5% of patients
  • they waste valuable nursing resources
  • NICE and ESO VTE guidelines recommend that GCS should not be used in stroke patients

CLOTS Trials Collaboration. Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke. Reference: (CLOTS Trial 1): a multicentre, randomized controlled trial. Lancet 2009;373:1958-1965. CLOTS Trial 1 paper. CLOTS Trial 1 content from STARs Advancing Module 11. CLOTS trial design

Heparin or low molecular weight heparin

These do reduce the risk of DVT but:

  • They significantly increase the risk of important bleeding
  • No significant reduction in deaths
  • No improvement in functional outcomes
  • They are not recommended for routine use after stroke by Intercollegiate (NICE) OR ESO VTE guidelines for ischaemic stroke
  • LMWH may be used in patients at high risk of DVT AND low risk of bleeding
  • But unclear how these are defined
Reference:

Lederle FA, Zylla D, MacDonald R, Wilt TJ. Venous Thromboembolism Prophylaxis in Hospitalized Medical Patients and Those With Stroke: A Background Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med 2011;155:602-615. Link to paper.

Lets review Angela’s pathway

Angela’s pathway

Angela’s pathway was fairly straight forward – typical for a patient who is suitable for thrombolysis but not thrombectomy.

Angela's pathway from 999 call to treatment and discharge

Outcome and Key messages

Outcome

Iain makes a rapid recovery with no complications from the procedure. On the second day he is transferred from the HASU to the stroke unit but within two days he has only a minor speech deficit.

He is discharged home with follow up in the community. He continues on Apixaban to reduce the risk of a further ischaemic stroke.

Key messages

  • Patients on oral anticoagulants are not usually eligible for thrombolysis (unless on Warfarin and INR <1.6)
  • Thrombectomy is an effective treatment for patients with Large Artery Occlusion (LAO) who cannot receive thrombolysis
  • Time is Brain – delays in delivering thrombectomy need to be minimised
  • Thrombectomy is a complex procedure, delivered by a team of experts in a specialist facility
  • Thrombectomy has some major complications – those caring for patients after the procedure need to be alert to these and know how to provide immediate treatment.