Multiple Electrode Aggregometry to Assess Platelet Function in Patients Undergoing Hip Joint Alloplasty With and Without Bone Cement (APJAB)

September 13, 2022 updated by: Marek Janiak, Medical University of Warsaw
The aim of the study is to assess blood platelet function and activation in patients undergoing both cement and non cement hip joint total alloplasty. Bone cement is used as a special biomaterial to help fix a hip prosthesis in place but is associated with bone cement implantation syndrome causing such complications as hypotension, cardiac arrhythmias. The pathophysiology of bone cement implantation syndrome is not fully known but one theory supports formation of clots in the bloodstream. This directly would activate platelets but no such study has been performed in humans. As bone reaming could potentially cause platelet activation even without bone cement, the study involves a control group of patients undergoing non cemented joint alloplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-005
        • I Department of Anesthesiology and Intensive Care Warsaw Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing hip arthroplasty

Description

Inclusion Criteria:

  • Patients qualified for hip arthroplasty
  • Signed consent for study
  • No abnormality in coagulation screen
  • Not taking regular antiplatelet medication except small dose of acetylsalicylic acid

Exclusion Criteria:

  • Lack of consent
  • Low platelet count (<100 thousand) in standard preoperative full blood count
  • On regular antiplatelet medication (except 75mg acetylsalicylic acid)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hip arthroplasty with bone cement
Patients undergoing hip replacement surgery with bone cement use: blood samples taken before cement use and after cement prosthesis fixation.
Other: Blood sample 1
Blood taken before prosthesis implantation
Other: Blood sample 2
Blood taken after prosthesis implantation
Non cement hip arthroplasty
Patients undergoing hip replacement surgery without bone cement. Blood samples taken before bone reaming and after implantation of femoral prosthesis.
Other: Blood sample 1
Blood taken before prosthesis implantation
Other: Blood sample 2
Blood taken after prosthesis implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in platelet aggregation as expressed by height and slope of curve
Time Frame: Up to 30 minutes
Differences in increase of impedance to a current during multiple electrode aggregometry measured as area under curve (AUC) expressed in units AU*minute which is derived from the velocity and maximum height of the aggregometry curves
Up to 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 12, 2017

Primary Completion (ACTUAL)

September 13, 2022

Study Completion (ACTUAL)

September 13, 2022

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 14, 2017

First Posted (ACTUAL)

April 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APJAB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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