CLOTS

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CLOTS

• Clots in Legs Or sTockings after Stroke
• A multicentre randomised trial to evaluate
  graduated compression stockings
• Funded by Medical Research Council
• Chest Heart Stroke Scotland
• Adopted by Stroke Research Network
• Carol Williams University of Edinburgh

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In hospitalised stroke patients

• Direct thrombus imaging with MRI shows
• Above knee DVT in 17
• Pulmonary embolism in about 10
• Any Venous thromboembolism in 40
• Clinically apparent in lt5

Kelly et al
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The risks costs of Graduated Compression
Stockings

• Do these risks outweigh the potential benefits of
  stockings?

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Long or short stockings?
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Compression in stroke
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Research Questions

• Do full length graduated compression stockings
  (TED) reduce the frequency of DVT after stroke?
• Are full length graduated compression stockings
  more effective than below knee stockings?

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Research Questions

• Do full length graduated compression stockings
  (TED) reduce the frequency of DVT after stroke?
• 6.30 pm 19th May 2009

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Research Questions

• Trial 2 for you and your patients
• Are full length graduated compression stockings
  more effective than below knee stockings?

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Progress so far
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Recruitment Jan 09

• Trial 1- 2518- stopped recruiting on1st Dec 08
• Patient Number 5000 from Bham Heartlands
  thanks to Dr Shinton and team
• Todays total
• 5020
• Currently recruiting about 120 per month

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GCS unlikely to be enough

• If CLOTS shows stockings are effective
• Likely to be a clinically significant residual
  risk of above knee DVT 8-10
• Need to find additional effective treatment to
  prevent DVT
• Especially in high risk patients
• If ineffective even more important to find an
  alternative e.g. IPC

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CLOTS 3 Intermittent PneumaticCompression
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Systematic review of RCTs ofPhysical methods
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Why are stroke patients different from surgical
patients?

• In surgery
• IPC applied before
• brief period of paralysis
• early mobilisation
• no routine use of aspirin
• patients at low risk of IPC complications

• In stroke
• IPC applied after
• paralysis may persist
• prolonged immobilisation
• lower compliance?
• aspirin used routinely
• many have PVD/diabetes

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Meta-analysis of RCTsof IPC in stroke (fixed
effects model)
Turpie mixed population including
stroke Pambianco enrolled on admission to
rehabilitation Lacut all intracranial
haemorrhage
No effect
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Research questions

• Does the addition of IPC to routine care reduce
  the risk of venous thromboembolism in
  hospitalised stroke patients?
• Is it a practical and acceptable method of
  prophylaxis?
• Is it associated with any adverse effects?

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CLOTS Trial 3
Immobile Stroke patient Day 0-3 of admission
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Routine Care

• Long stockings if Trial 1 demonstrates their
  effectiveness and Trial 2 their superiority over
  short ones
• Long or short if Trial 1 shows long work and
  trial 2 suggests short as good
• No stockings if Trial 1 shows no benefit

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CLOTS 3

• Will exploit
• Existing network of collaborating centres
• Widespread knowledge of protocol
• Central coordination which has proven
  effectiveness
• Existing trial systems for randomisation, data
  capture etc take advantage of

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Plan

• Chief Scientist office for transition funding
  (Trial 1 2 to 3)
• Covidien for equipment (sleeves and controllers)
  and support for training
• Applying to Health Technology Assessment Board of
  NHS for main phase funding for Trial 3 when know
  results of Trial 1

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www.clotstrial.com