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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Total Hip Replacement
- Sponsor
- Medical University of Warsaw
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- INTEM parameters change from preoperative to postoperative values
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Jan Pluta
Principal Investigator
Medical University of Warsaw
Eligibility Criteria
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
Outcomes
Primary Outcomes
INTEM parameters change from preoperative to postoperative values
Time Frame: 30 minutes before and 30 minutes after surgery
EXTEM parameters change from preoperative to postoperative values
Time Frame: 30 minutes before and 30 minutes after surgery
FIBTEM parameter change from preoperative to postoperative values
Time Frame: 30 minutes before and 30 minutes after surgery
Secondary Outcomes
- Total volume of infused fluids(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(Blood loss as measured during surgery)
- Hip Disability and Osteoarthritis Outcome Score (HOOS)(The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery)
- The 36-Item Short Form Health Survey (SF-36)(The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery)
- Visual Analogue Scale (VAS) score(The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery)