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Surgical Tourniquets and Cerebral Emboli

Surgical Tourniquets and Cerebral Emboli Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02240732
Enrollment
12
Registered
2014-09-16
Start date
2014-09-30
Completion date
2015-04-30
Last updated
2015-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, RA, Trauma

Brief summary

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?

Interventions

None listed

Sponsors

University Hospitals Coventry and Warwickshire NHS Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Emboli on Transcranial DopplerIntra-operative2 independent technicians will verify the number of emboli detected. Non-invasive
MRI brain scan - presence of EmboliPost-operatively, prior to dischargeReviewed by Professor of radiology - presence, number and volume of diffusion weighted lesions

Secondary

MeasureTime frameDescription
Mini-mental state examinationPre-operative vs Post-operativeSet of 30 questions which test cognitive function

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026