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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Total Hip Replacement; Thromboelastometry; Bone Neoplasm of Hip
• Intervention / Treatment: Diagnostic test: Rotational thromboelastometry

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Marek Janiak, MD; Phone Number: 0048225021724; Email: mjaniak1@wum.edu.pl

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 02-005
      • Recruiting
      • I Department of Anesthesiology and Intensive Care Warsaw Medical University
      • Contact: Marek Janiak, MD; Phone Number: 0048225021724; Email: klinanest1@wum.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing elective total hip replacement

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing THR with no known bone neoplasm; Pre- and postoperative blood sampling for ROTEM assessment in THR patients	Diagnostic test: Rotational thromboelastometry; 1.8 ml blood sample; Other Names: ROTEM
Patients undergoing THR with known bone neoplasm; Pre- and postoperative blood sampling for ROTEM assessment before and after THR in patients with bone neoplasm	Diagnostic test: Rotational thromboelastometry; 1.8 ml blood sample; Other Names: ROTEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
INTEM parameters change from preoperative to postoperative values	30 minutes before and 30 minutes after surgery
EXTEM parameters change from preoperative to postoperative values	30 minutes before and 30 minutes after surgery
FIBTEM parameter change from preoperative to postoperative values	30 minutes before and 30 minutes after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total volume of infused fluids	Crystalloids, blood products	From first fluid on day of surgery to end of surgery, an average of 12 hours
Pre- and postoperative haemoglobin and haematocrit		From day before surgery to postoperative day 3
Intraoperative blood loss	Amount of blood loss in millilitres	Blood loss as measured during surgery
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of thrombotic events	Pulmonary embolism, deep and superficial vein thrombosis	up to 12 months after surgery

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Jan Pluta, MD, Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Neoplasms; Bone Neoplasms; Intraoperative Complications
• Other Study ID Numbers: ROTEM-THR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No