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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04442373
Other study ID # ROTEM-THR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source Medical University of Warsaw
Contact Marek Janiak, MD
Phone 0048225021724
Email mjaniak1@wum.edu.pl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Diagnostic Test:
Rotational thromboelastometry
1.8 ml blood sample

Locations

Country Name City State
Poland I Department of Anesthesiology and Intensive Care Warsaw Medical University Warsaw Mazowieckie

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Other Rate of thrombotic events Pulmonary embolism, deep and superficial vein thrombosis up to 12 months after surgery
Primary INTEM parameters change from preoperative to postoperative values 30 minutes before and 30 minutes after surgery
Primary EXTEM parameters change from preoperative to postoperative values 30 minutes before and 30 minutes after surgery
Primary FIBTEM parameter change from preoperative to postoperative values 30 minutes before and 30 minutes after surgery
Secondary Total volume of infused fluids Crystalloids, blood products From first fluid on day of surgery to end of surgery, an average of 12 hours
Secondary Pre- and postoperative haemoglobin and haematocrit From day before surgery to postoperative day 3
Secondary Intraoperative blood loss Amount of blood loss in millilitres Blood loss as measured during surgery
Secondary Hip Disability and Osteoarthritis Outcome Score (HOOS) Instrument for measuring outcome following surgery with higher scores representing better function. Score from 0 to 100. The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery
Secondary The 36-Item Short Form Health Survey (SF-36) Health related Quality of Life measure. Higher score indicates better health state with eight scaled scores each from 0 to 100. The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery
Secondary Visual Analogue Scale (VAS) score The ends of the scale are defined as the extreme limits of the pain. Orientated from the left (no pain) to the right (worst imaginable pain) measured in millimeters from 0 to 100. The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery
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