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

Completed

• Conditions: Platelet Aggregation; Arthroplasty; Methylmethacrylate Embolism
• Interventions: Other: Blood sample 1; Other: Blood sample 2

• Registration Number: NCT03121378
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-12
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-14
• Study First Posted: 2017-04-20
• Status Verified: 2022-09
• Primary Completion: 2022-09-13
• Study Completion: 2022-09-13
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in platelet aggregation as expressed by height and slope of curve	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

Trial Locations

Locations (1)

I Department of Anesthesiology and Intensive Care Warsaw Medical University; 🇵🇱 Warsaw, Mazowieckie, Poland