Revision Total Hip Replacement Arthroplasty and Hematologic Variables

Avascular Necrosis of Hip Clinical Trial

Official title:

Relations Between Hematologic Variables and Postoperative Bleeding and Transfusion in Revision Total Hip Replacement Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951741
• Other study ID #: B-1502/288-302
• Status: Completed
• Phase: N/A
• First received: October 24, 2016
• Last updated: October 10, 2017
• Start date: April 2015
• Est. completion date: February 2017

Study information

• Verified date: October 2017
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Revision total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• revision total hip replacement

Exclusion Criteria:

• hematologic disease

• anticoagulant medication

• American Society of Anesthesiologists physical status 4 and 5

Related Conditions & MeSH terms

• Avascular Necrosis of Hip
• Degenerative Hip Joint Disease
• Joint Diseases
• Necrosis
• Osteoarthritis, Hip

Intervention

Other:
• RTHRA group
hematologic variables measurement in patients undergoing revision total hip replacement

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of FIBTEM	FIBTEM: one of the measurements of the rotational thromboelastometry	5 minutes before initiation of anesthesia and 5 minutes after finishing operation
Secondary	volume of infused fluid during operation	Infused total crystalloid and colloid volume during the operation will be recorded	Period from starting to finishing the operation (During operation, an expected average of 3 hours)
Secondary	intraoperative urine output		Period from starting to finishing the operation (During operation, an expected average of 3 hours)
Secondary	transfusion units	Red blood cell	Period from starting to finishing the operation (During operation, an expected average of 3 hours) and postoperative first day
Secondary	postoperative bleeding volume		postoperative 72 hours
Secondary	Hemoglobin		preoperative day 1
Secondary	Hemoglobin		postoperative day 4
Secondary	Hematocrit		preoperative day 1
Secondary	Hematocrit		postoperative day 4
Secondary	Platelet count		preoperative day 1
Secondary	Platelet count		postoperative day 4
Secondary	prothrombin time_international normalized ratio		preoperative day 1
Secondary	prothrombin time_international normalized ratio		postoperative day 1
Secondary	activated partial prothrombin time		preoperative day 1
Secondary	activated partial prothrombin time		postoperative day 1
Secondary	fibrinogen concentration		preoperative day 1
Secondary	fibrinogen concentration		postoperative day 1