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

Arthroplasty Clinical Trial

— APJAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03121378
• Other study ID #: APJAB
• Status: Completed
• Start date: April 12, 2017
• Est. completion date: September 13, 2022

Study information

• Verified date: September 2022
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthroplasty
• Embolism
• Methylmethacrylate Embolism
• Platelet Aggregation

Intervention

Other:
• Blood sample 1
Blood taken before prosthesis implantation
• Blood sample 2
Blood taken after prosthesis implantation

Locations

Country	Name	City	State
Poland	I Department of Anesthesiology and Intensive Care Warsaw Medical University	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in platelet aggregation as expressed by height and slope of curve	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