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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03121378

Acronym

APJAB

Enrollment

Registered

2017-04-20

Start date

2017-04-12

Completion date

2022-09-13

Last updated

2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Methylmethacrylate Embolism, Platelet Aggregation

Keywords

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

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.

Interventions

OTHERBlood sample 1

Blood taken before prosthesis implantation

OTHERBlood sample 2

Blood taken after prosthesis implantation

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026