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

Total Hip Replacement Clinical Trial

— I-SIGHT-THR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04442373
• Other study ID #: ROTEM-THR
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Bone Neoplasm of Hip
• Bone Neoplasms
• Intraoperative Complications
• Neoplasms
• Thromboelastometry
• Total Hip Replacement

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