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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing THR with no known bone neoplasm | Pre- and postoperative blood sampling for ROTEM assessment in THR patients |
| |
| Patients undergoing THR with known bone neoplasm | Pre- and postoperative blood sampling for ROTEM assessment before and after THR in patients with bone neoplasm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotational thromboelastometry | Diagnostic Test | 1.8 ml blood sample |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of thrombotic events | Pulmonary embolism, deep and superficial vein thrombosis | up to 12 months after surgery |
Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing elective total hip replacement
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marek Janiak, MD | Contact | 0048225021724 | mjaniak1@wum.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Jan Pluta, MD | Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I Department of Anesthesiology and Intensive Care Warsaw Medical University | Recruiting | Warsaw | Masovian Voivodeship | 02-005 | Poland |
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Arterial blood samples
|
| 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 |