Impact of Surgical Injury on Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Neoplasm
- Conditions
- ThromboelastometryTotal Hip ReplacementBone Neoplasm of Hip
- Interventions
- Diagnostic Test: Rotational thromboelastometry
- Registration Number
- NCT04442373
- Lead Sponsor
- Medical University of Warsaw
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Adult patients undergoing primary elective total hip replacement
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients undergoing THR with known bone neoplasm Rotational thromboelastometry Pre- and postoperative blood sampling for ROTEM assessment before and after THR in patients with bone neoplasm Patients undergoing THR with no known bone neoplasm Rotational thromboelastometry Pre- and postoperative blood sampling for ROTEM assessment in THR patients
- Primary Outcome Measures
Name Time Method 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
Name Time Method Total volume of infused fluids From first fluid on day of surgery to end of surgery, an average of 12 hours Crystalloids, blood products
Pre- and postoperative haemoglobin and haematocrit From day before surgery to postoperative day 3 Intraoperative blood loss Blood loss as measured during surgery Amount of blood loss in millilitres
Hip Disability and Osteoarthritis Outcome Score (HOOS) The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery Instrument for measuring outcome following surgery with higher scores representing better function. Score from 0 to 100.
The 36-Item Short Form Health Survey (SF-36) The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery Health related Quality of Life measure. Higher score indicates better health state with eight scaled scores each from 0 to 100.
Visual Analogue Scale (VAS) score The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery 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.
Trial Locations
- Locations (1)
I Department of Anesthesiology and Intensive Care Warsaw Medical University
🇵🇱Warsaw, Mazowieckie, Poland