Surgical Tourniquets and Cerebral Emboli

NCT02240732 | Completed DMC

• 1 other identifier: STCE2.0
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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?

Conditions

Osteoarthritis; RA; Trauma

Outcome Measures

Primary Outcomes (2)

• Number of Emboli on Transcranial Doppler

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

  Intra-operative

• MRI brain scan - presence of Emboli

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

  Post-operatively, prior to discharge

Secondary Outcomes (1)

• Mini-mental state examination

  Pre-operative vs Post-operative

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are due to have a total knee replacement.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead

Study Sites (1)

University Hospital Warwickshire and Coventry

Coventry, CV2 2DX, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 21161177 BACKGROUND

• 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. doi: 10.1097/00000539-199510000-00017.

  PMID: 7574006 BACKGROUND

• 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. doi: 10.1016/0140-6736(93)92414-o.

  PMID: 8096961 BACKGROUND

• Arroyo JS, Garvin KL, McGuire MH. Fatal marrow embolization following a porous-coated bipolar hip endoprosthesis. J Arthroplasty. 1994 Aug;9(4):449-52. doi: 10.1016/0883-5403(94)90057-4.

  PMID: 7964778 BACKGROUND

• 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. doi: 10.1161/01.str.25.7.1393.

  PMID: 8023354 BACKGROUND

• 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.

  PMID: 14765873 BACKGROUND

• 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.

  PMID: 2295174 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Wounds and Injuries

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Victoria Gibbs, BA, MBBS

  UHCW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 16, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 30, 2015

Record last verified: 2015-06

Locations

GB (1)