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NCT Number: NCT02240732

Surgical Tourniquets and Cerebral Emboli

BACKGROUND In 2012 76,497 primary total knee (TKR) replacements were performed in England, Wales and Northern Ireland . Traditionally TKR surgery is undertaken with the aid of a surgical tourniquet. A surgical tourniquet is an occlusive device applied around a patient's leg. The tourniquet squeezes the leg (including blood vessels within the leg) and can therefore reduce the amount of bleeding that occurs while it is inflated. An intraoperative tourniquet can therefore help to improve the surgical field of view. Although the majority of surgeons prefer to undertake TKR surgery using a tourniquet a small but increasing number are now not pursuing these devices.

There is robust evidence that the risk of deep vein thrombosis is increased if a tourniquet is used for TKR surgery. In addition embolic material in the venous system have been observed following TKR surgery and have been noted to be present in the right atrium with transoesophageal (TOE) echo intra-operatively. , Significant and potentially life threatening emboli have been documented to enter the cerebral circulation via pulmonary arterio-venous shunts and patent foramen ovale (PFO) (27% of patients at autopsy) , . The clinical manifestations of cerebral emboli post tourniquet deflation in TKR are not fully understood. Fat embolism syndrome and post-operative confusion in TKR patients may be the result of emboli formed during a TKR. ,

AIM

* Is there evidence of emboli entering the cerebral circulation following tourniquet deflation in TKR surgery? * Is there evidence of MRI detectable brain lesions and or any clinical change in cognition compared in patients undergoing TKR surgery with a tourniquet compared to those that do not have a tourniquet?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Warwickshire and Coventry

Coventry, CV2 2DX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • i.Aged >18
  • ii.Undergoing elective TKR
  • iii.Able to give written informed consent
  • iv.No contraindications to MR imaging

Exclusion criteria

  • i. Ages <16
  • ii. Not able to give written informed consent
  • iv. Contraindications to MR imaging

Treatment and study plan

Primary outcomes

  1. Number of Emboli on Transcranial Doppler

    Time frame: Intra-operative

    2 independent technicians will verify the number of emboli detected. Non-invasive

  2. MRI brain scan - presence of Emboli

    Time frame: Post-operatively, prior to discharge

    Reviewed by Professor of radiology - presence, number and volume of diffusion weighted lesions

Secondary outcomes

  1. Mini-mental state examination

    Time frame: Pre-operative vs Post-operative

    Set of 30 questions which test cognitive function

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Registry information

Official study title

Surgical Tourniquets and Cerebral Emboli Pilot Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 16, 2014
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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