Clinical trial NCT04442373: Impact of Surgical Injury on Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Neoplasm
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Total Hip Replacement
Thromboelastometry
Bone Neoplasm of Hip
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective total hip replacement

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: INTEM parameters change from preoperative to postoperative values
timeFrame: 30 minutes before and 30 minutes after surgery
measure: EXTEM parameters change from preoperative to postoperative values
timeFrame: 30 minutes before and 30 minutes after surgery
measure: FIBTEM parameter change from preoperative to postoperative values
timeFrame: 30 minutes before and 30 minutes after surgery
Secondary outcomes:
measure: Total volume of infused fluids
timeFrame: From first fluid on day of surgery to end of surgery, an average of 12 hours
measure: Pre- and postoperative haemoglobin and haematocrit
timeFrame: From day before surgery to postoperative day 3
measure: Intraoperative blood loss
timeFrame: Blood loss as measured during surgery
measure: Hip Disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery
measure: The 36-Item Short Form Health Survey (SF-36)
timeFrame: The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery
measure: Visual Analogue Scale (VAS) score
timeFrame: The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery
Other outcomes:
measure: Rate of thrombotic events
timeFrame: up to 12 months after surgery
Locations:
city: Warsaw
country: Poland
facility: I Department of Anesthesiology and Intensive Care Warsaw Medical University
state: Mazowieckie
Study officials:
affiliation: Medical University of Warsaw
name: Jan Pluta, MD
role: PRINCIPAL_INVESTIGATOR
References: