Surgical Tourniquets and Cerebral Emboli

Completed

• Conditions: RA; Trauma; Osteoarthritis

• Registration Number: NCT02240732
• Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-16
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-28
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Emboli on Transcranial Doppler	Intra-operative	2 independent technicians will verify the number of emboli detected. Non-invasive
MRI brain scan - presence of Emboli	Post-operatively, prior to discharge	Reviewed by Professor of radiology - presence, number and volume of diffusion weighted lesions

Secondary Outcome Measures

Name	Time	Method
Mini-mental state examination	Pre-operative vs Post-operative	Set of 30 questions which test cognitive function

Trial Locations

Locations (1)

University Hospital Warwickshire and Coventry; 🇬🇧 Coventry, United Kingdom