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OpenTrials
Completed

NCT Number: NCT03121378

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

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.

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Key information

Conditions

Arthroplasty Methylmethacrylate Embolism Platelet Aggregation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

I Department of Anesthesiology and Intensive Care Warsaw Medical University

Warsaw, Masovian Voivodeship, 02-005, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood sample 1

Other

Blood taken before prosthesis implantation

Blood sample 2

Other

Blood taken after prosthesis implantation

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Acronym: APJAB

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2017
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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