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

NCT03121378 | Completed

• 1 other identifier: APJAB
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty; Methylmethacrylate Embolism; Platelet Aggregation

Keywords

Hip Joint Alloplasty; Bone Cements; Impedance Aggregometry; Platelet Activation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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; Other: Blood sample 2

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; Other: Blood sample 2

Interventions

Blood sample 1 OTHER

Blood taken before prosthesis implantation

Hip arthroplasty with bone cement; Non cement hip arthroplasty

Blood sample 2 OTHER

Blood taken after prosthesis implantation

Hip arthroplasty with bone cement; Non cement hip arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing hip arthroplasty

You may qualify if:

• 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

You may not qualify if:

• Lack of consent
• Low platelet count (\<100 thousand) in standard preoperative full blood count
• On regular antiplatelet medication (except 75mg acetylsalicylic acid)

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

I Department of Anesthesiology and Intensive Care Warsaw Medical University

Warsaw, Masovian Voivodeship, 02-005, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

3ml Blood samples.

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 20, 2017
• Study Start: April 12, 2017
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)