Bone Neoplasm of Hip, Thromboelastometry, Total Hip Replacement
Conditions
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.
Interventions
DIAGNOSTIC_TESTRotational thromboelastometry
1.8 ml blood sample
Sponsors
Medical University of Warsaw
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FIBTEM parameter 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 |
| INTEM parameters change from preoperative to postoperative values | 30 minutes before and 30 minutes after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of thrombotic events | up to 12 months after surgery | Pulmonary embolism, deep and superficial vein thrombosis |
Countries
Poland
Contacts
Primary ContactMarek Janiak, MD
Outcome results
None listed