CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT02240732
NCT02240732N/ACompleted

Surgical Tourniquets and Cerebral Emboli Pilot Study

University Hospitals Coventry and Warwickshire NHS Trust·observational·Posted Sep 16, 2014·Updated Jun 30, 2015

In Brief

An observational study for Osteoarthritis and 2 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed 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?

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 16, 2014
Enrollment StartSep 1, 2014
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.8 years ago