Examination of inflammatory markers associated with Total Knee Replacement surgery, and the association with coagulopathies (bleeding/clotting disorders)

Examination of inflammatory markers associated with Total Knee Replacement surgery, and the association with coagulopathies using ROTEM (Rotational thromboelastometry)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12617000444381

Acronym

ALM Pilot Study

Enrollment

Registered

2017-03-27

Start date

2015-03-05

Completion date

2017-02-17

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary aim of this project is to examine specific inflammatory markers and define the association with coagulopathies in patients undergoing elective total knee arthroplasty (TKA). A total of 20 patients will be observed in the trial; these patients are all undergoing Primary TKA for treatment of osteoarthritis (OA). There are multiple traumatic events that occur over the duration of TKA surgery, all which illicit some form of inflammatory and immune response; it is this response that we are interested in examining. Disruption to the skin, bone and synovial membrane all trigger an inflammatory cytokine cascade. The concentrations in peripheral blood of selected cytokines have been reported to undergo more rapid increases and quicker return to normal values after surgery than either CRP or ESR suggesting they may be better markers for risk of early infection following TKR. There has been limited research to determine whether there is an association between particular inflammatory cytokine markers, coagulopathies and clinical outcomes post-surgery. We aim to examine the changes in concentration of key inflammatory cytokine markers in peripheral blood of elective TKA patients during and after surgery and to define the association with coagulopathies. Patients undergoing unilateral TKA for OA will have blood samples taken at six time-points peri-operative and on the ward at day one and three post-surgery The blood samples will be used for analysis of key inflammatory markers and coagulopathy parameters. Patient-reported health outcomes relating to pain, analgesia, sleep and joint function will be completed pre and post-surgery. Patient rehabilitation post-surgery will be consistent with current standard protocols with the exception of NSAID administration, unless otherwise advised. The use of tranexamic acid during TKA to treat or prevent excessive blood loss during surgery will be recorded. Data collected will be analysed to identify significant changes in both coagulation and inflammatory markers in response to trauma during surgery and in recovery, Correlations between biological markers and patient health outcomes will be explored.

Interventions

Patients will undergo a series of blood tests during their routine Total Knee Replacement surgery (TKR) and post-operative whilst in the ward during recovery. There are 6 time points at which blood will be taken and analysed for inflammatory and coagulopathic response to TKR surgery. Four (4) of the blood tests will be conducted under anaesthetic during surgery and soon after surgery in the recovery room, Two (2) samples will be conducted on the ward, post-operatively. Blood will be drawn by

Eligibility

Sex/Gender

All

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

Patients scheduled to undergo primary unilateral total knee replacement (TKR) will be eligible for inclusion in this study, Additional inclusion criteria that must be met are: Age 40 - 75 Osteoarthritis of the knee; radiologically confirmed Medically fit to undergo TKR

Exclusion criteria

Patients taking anti-coagulant medication or have an existing medical condition which may increase their risk for coagulopathy during surgery. Patients with known chronic inflammatory diseases, recent antibiotic treatment or inter-current infections before surgery, vascular disorders or autoimmune disorders will be excluded as cytokine response can be abnormal in response to these conditions.

Outcome results