- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02240732
Surgical Tourniquets and Cerebral Emboli
Surgical Tourniquets and Cerebral Emboli Pilot Study
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?
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Coventry, Reino Unido, CV2 2DX
- University Hospital Warwickshire and Coventry
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Emboli on Transcranial Doppler
Periodo de tiempo: Intra-operative
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2 independent technicians will verify the number of emboli detected.
Non-invasive
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Intra-operative
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MRI brain scan - presence of Emboli
Periodo de tiempo: Post-operatively, prior to discharge
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Reviewed by Professor of radiology - presence, number and volume of diffusion weighted lesions
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Post-operatively, prior to discharge
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mini-mental state examination
Periodo de tiempo: Pre-operative vs Post-operative
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Set of 30 questions which test cognitive function
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Pre-operative vs Post-operative
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Victoria Gibbs, BA, MBBS, UHCW
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STCE2.0
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