Examining blood clotting changes in hip replacement surgery patients, especially those with cancer
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
Medical University of Warsaw · NCT04442373
This study is testing how hip replacement surgery affects blood clotting in patients, especially those with cancer, to better understand any problems that might arise.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Warsaw (other) |
| Locations | 1 site (Warsaw, Mazowieckie) |
| Trial ID | NCT04442373 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of surgical injury on blood clotting tests in patients undergoing total hip replacement (THR). It focuses on quantifying changes in clot formation dynamics, particularly in a subgroup of patients with bone neoplasms. The study utilizes rotational thromboelastometry, a point-of-care assay, to assess coagulation disorders that may arise due to extensive tissue injury and blood loss during surgery. By analyzing these changes, the study aims to improve understanding of haemostatic abnormalities in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adult patients scheduled for primary elective total hip replacement.
Not a fit: Patients with active thrombosis, coagulopathy, or those on certain antithrombotic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient outcomes by optimizing blood management strategies during total hip replacement surgeries.
How similar studies have performed: While the approach of using thromboelastometry in surgical settings is established, the specific focus on THR in cancer patients is less common, indicating a novel aspect of this study.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Warsaw, Mazowieckie
- I Department of Anesthesiology and Intensive Care Warsaw Medical University — Warsaw, Mazowieckie, Poland (RECRUITING)
Study contacts
- Principal investigator: Jan Pluta, MD — Medical University of Warsaw
- Study coordinator: Marek Janiak, MD
- Email: mjaniak1@wum.edu.pl
- Phone: 0048225021724
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Total Hip Replacement, Thromboelastometry, Bone Neoplasm of Hip