Surgical Tourniquets and Cerebral Emboli

• Sponsor: University Hospitals Coventry and Warwickshire NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT02240732
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; RA; Trauma

Study Design

• Study Type: Observational
• Actual Enrollment: 12 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Surgical Tourniquets and Cerebral Emboli Pilot Study
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Total knee replacement patients Patients who are due to have a total knee replacement will be studied to look for the presence of Emboli. Observational with imaging.

Outcome Measures

Primary Outcome Measures

1. Number of Emboli on Transcranial Doppler [Intra-operative]

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

2. 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

1. Mini-mental state examination [Pre-operative vs Post-operative]

   Set of 30 questions which test cognitive function

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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:

• 1. Ages <16
• 1. Not able to give written informed consent
• 1. Contraindications to MR imaging

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Warwickshire and Coventry	Coventry		United Kingdom	CV2 2DX

Sponsors and Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust

Investigators

• Principal Investigator: Victoria Gibbs, BA, MBBS, UHCW

Study Documents (Full-Text)

None provided.

More Information

Publications

• Arroyo JS, Garvin KL, McGuire MH. Fatal marrow embolization following a porous-coated bipolar hip endoprosthesis. J Arthroplasty. 1994 Aug;9(4):449-52.
• Caillouette JT, Anzel SH. Fat embolism syndrome following the intramedullary alignment guide in total knee arthroplasty. Clin Orthop Relat Res. 1990 Feb;(251):198-9.
• Parmet JL, Berman AT, Horrow JC, Harding S, Rosenberg H. Thromboembolism coincident with tourniquet deflation during total knee arthroplasty. Lancet. 1993 Apr 24;341(8852):1057-8.
• Parmet JL, Horrow JC, Pharo G, Collins L, Berman AT, Rosenberg H. The incidence of venous emboli during extramedullary guided total knee arthroplasty. Anesth Analg. 1995 Oct;81(4):757-62.
• Pugsley W, Klinger L, Paschalis C, Treasure T, Harrison M, Newman S. The impact of microemboli during cardiopulmonary bypass on neuropsychological functioning. Stroke. 1994 Jul;25(7):1393-9.
• Riding G, Daly K, Hutchinson S, Rao S, Lovell M, McCollum C. Paradoxical cerebral embolisation. An explanation for fat embolism syndrome. J Bone Joint Surg Br. 2004 Jan;86(1):95-8.
• Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY. Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1121-30. doi: 10.1007/s00167-010-1342-7. Epub 2010 Dec 15. Review.

• Responsible Party: Victoria Gibbs, Doctor, University Hospitals Coventry and Warwickshire NHS Trust
• ClinicalTrials.gov Identifier: NCT02240732
• Other Study ID Numbers: STCE2.0
• First Posted: Sep 16, 2014
• Last Update Posted: Jun 30, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Intracranial Embolism

Study Results

No Results Posted as of Jun 30, 2015