Impact of Surgical Injury on Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Neoplasm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Total Hip Replacement Thromboelastometry Bone Neoplasm of Hip

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing THR with no known bone neoplasm

Pre- and postoperative blood sampling for ROTEM assessment in THR patients

Rotational thromboelastometry

Intervention Type DIAGNOSTIC_TEST

1.8 ml blood sample

Patients undergoing THR with known bone neoplasm

Pre- and postoperative blood sampling for ROTEM assessment before and after THR in patients with bone neoplasm

Rotational thromboelastometry

Intervention Type DIAGNOSTIC_TEST

1.8 ml blood sample

Interventions

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Rotational thromboelastometry

1.8 ml blood sample

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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ROTEM

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No