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

NCT ID: NCT03121378

Last Updated: 2022-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-12

Study Completion Date

2022-09-13

Brief Summary

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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.

Detailed Description

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Conditions

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Arthroplasty Methylmethacrylate Embolism Platelet Aggregation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Blood sample 1

Intervention Type OTHER

Blood taken before prosthesis implantation

Blood sample 2

Intervention Type OTHER

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.

Blood sample 1

Intervention Type OTHER

Blood taken before prosthesis implantation

Blood sample 2

Intervention Type OTHER

Blood taken after prosthesis implantation

Interventions

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Blood sample 1

Blood taken before prosthesis implantation

Intervention Type OTHER

Blood sample 2

Blood taken after prosthesis implantation

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Marek Janiak

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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I Department of Anesthesiology and Intensive Care Warsaw Medical University

Warsaw, Masovian Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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APJAB

Identifier Type: -

Identifier Source: org_study_id

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