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

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ClinicalTrials.gov Identifier: NCT03121378
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Marek Janiak, Medical University of Warsaw

Brief Summary:
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.

Condition or disease Intervention/treatment
Arthroplasty Methylmethacrylate Embolism Platelet Aggregation Other: Blood sample 1 Other: Blood sample 2

Study Type : Observational
Estimated Enrollment : 44 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Multiple Electrode Aggregometry to Assess Platelet Function in Patients Undergoing Hip Joint Alloplasty With and Without Bone Cement
Actual Study Start Date : April 12, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

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



Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
3ml Blood samples.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing hip arthroplasty
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121378


Contacts
Contact: Marek Janiak, Dr 0048225021721 klinanest1@wum.edu.pl

Locations
Poland
I Department of Anesthesiology and Intensive Care Warsaw Medical University Recruiting
Warsaw, Mazowieckie, Poland, 02-005
Contact: Marek Janiak, MD    0048225021724    klinanest1@wum.edu.pl   
Sponsors and Collaborators
Medical University of Warsaw

Responsible Party: Marek Janiak, Dr, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03121378     History of Changes
Other Study ID Numbers: APJAB
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marek Janiak, Medical University of Warsaw:
Hip Joint Alloplasty
Bone Cements
Impedance Aggregometry
Platelet Activation

Additional relevant MeSH terms:
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases