Clinical trial · Observational
Impact of Surgical Injury on Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Neoplasm
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Neoplasm of Hip | — | UNRESOLVED | — |
| Thromboelastometry | — | UNRESOLVED | — |
| Total Hip Replacement | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rotational thromboelastometry | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients undergoing THR with no known bone neoplasm
- description
- Pre- and postoperative blood sampling for ROTEM assessment in THR patients
- interventionNames
- Diagnostic Test: Rotational thromboelastometry
- label
- Patients undergoing THR with known bone neoplasm
- description
- Pre- and postoperative blood sampling for ROTEM assessment before and after THR in patients with bone neoplasm
- interventionNames
- Diagnostic Test: Rotational thromboelastometry
Primary outcomes (3)
- measure
- INTEM parameters change from preoperative to postoperative values
- timeFrame
- 30 minutes before and 30 minutes after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available