Impact of Surgical Injury on Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Neoplasm

Study Overview
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Brief Summary
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Total hip replacement (THR) is associated with extensive tissue injury and considerable blood loss that can be complicated by hyperfibrinolysis with an increased need for blood transfusion. THR in patients with cancer involving the hip joint, can reduce pain and improve or maintain the function and quality of life. However, these patients have an increased likelihood of haemostatic abnormalities, such as thrombosis or extensive blood loss. Rotational thromboelastometry is a point-of-care viscoelastic assay that can provide a measure of coagulation disorders in the above settings, and this is still under review. The objective of this prospective cohort study is to quantitate the changes in clot formation dynamics following THR with a subgroup analysis of patients with cancer.

Official Title
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Impact of Surgical Injury on Global Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Bone Neoplasm. A Single-centre Observational Prospective Trial

Conditions
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Total Hip Replacement, Thromboelastometry, Bone Neoplasm of Hip

Intervention / Treatment
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* Diagnostic Test: Rotational thromboelastometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients undergoing primary elective total hip replacement Exclusion Criteria: Patients unable to consent to trial Active deep and superficial vein thrombosis Coagulopathy in initial coagulation screen tests Platelet count below 100 thousand Patients on antithrombotic medications (except prophylactic low molecular weight heparins and acetylsalicylic acid up to 75 mg per day) Preoperative haemoglobin < 10 g/dl Female patients who are pregnant or nursing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing THR with no known bone neoplasm<br>Pre- and postoperative blood sampling for ROTEM assessment in THR patients | Diagnostic Test: Rotational thromboelastometry<br>* 1.8 ml blood sample<br>* Other names: ROTEM;|
| Patients undergoing THR with known bone neoplasm<br>Pre- and postoperative blood sampling for ROTEM assessment before and after THR in patients with bone neoplasm | Diagnostic Test: Rotational thromboelastometry<br>* 1.8 ml blood sample<br>* Other names: ROTEM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INTEM parameters change from preoperative to postoperative values |  | 30 minutes before and 30 minutes after surgery | 
| EXTEM parameters change from preoperative to postoperative values |  | 30 minutes before and 30 minutes after surgery | 
| FIBTEM parameter change from preoperative to postoperative values |  | 30 minutes before and 30 minutes after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total volume of infused fluids | Crystalloids, blood products | From first fluid on day of surgery to end of surgery, an average of 12 hours | 
| Pre- and postoperative haemoglobin and haematocrit |  | From day before surgery to postoperative day 3 | 
| Intraoperative blood loss | Amount of blood loss in millilitres | Blood loss as measured during surgery | 
| Hip Disability and Osteoarthritis Outcome Score (HOOS) | Instrument for measuring outcome following surgery with higher scores representing better function. Score from 0 to 100. | The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery | 
| The 36-Item Short Form Health Survey (SF-36) | Health related Quality of Life measure. Higher score indicates better health state with eight scaled scores each from 0 to 100. | The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery | 
| Visual Analogue Scale (VAS) score | The ends of the scale are defined as the extreme limits of the pain. Orientated from the left (no pain) to the right (worst imaginable pain) measured in millimeters from 0 to 100. | The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery |