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

NCT04442373 | Unknown

• 1 other identifier: ROTEM-THR
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Replacement; Thromboelastometry; Bone Neoplasm of Hip

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Total volume of infused fluids

  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

  Blood loss as measured during surgery

• Hip Disability and Osteoarthritis Outcome Score (HOOS)

  The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery

• The 36-Item Short Form Health Survey (SF-36)

  The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery

Other Outcomes (1)

• Rate of thrombotic events

  up to 12 months after surgery

Study Arms (2)

Patients undergoing THR with no known bone neoplasm

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

Diagnostic Test: Rotational thromboelastometry

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

Interventions

Rotational thromboelastometry DIAGNOSTIC_TEST

1.8 ml blood sample

Also known as: ROTEM

Patients undergoing THR with known bone neoplasm; Patients undergoing THR with no known bone neoplasm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing elective total hip replacement

You may qualify if:

• Adult patients undergoing primary elective total hip replacement

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

I Department of Anesthesiology and Intensive Care Warsaw Medical University

Warsaw, Masovian Voivodeship, 02-005, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Arterial blood samples

Study Officials

• Jan Pluta, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marek Janiak, MD

CONTACT

0048225021724; mjaniak1@wum.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: June 22, 2020
• Study Start: January 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

PL (1)