Impact of Surgical Injury on Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Neoplasm (I-SIGHT-THR)

Medical University of Warsaw

Status

Enrolling

Conditions

Total Hip Replacement

Bone Neoplasm of Hip

Thromboelastometry

Treatments

Diagnostic Test: Rotational thromboelastometry

Study type

Observational

Funder types

Other

Identifiers

NCT04442373

ROTEM-THR

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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