THRA_hematologic Variables

Avascular Necrosis of Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521858
• Other study ID #: B_1111_140_103
• Status: Completed
• Phase: N/A
• First received: January 9, 2012
• Last updated: August 28, 2013
• Start date: January 2012
• Est. completion date: February 2013

Study information

• Verified date: August 2013
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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: 73
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• avascular necrosis of hip

• total hip replacement arthroplasty

Exclusion Criteria:

• revision operation

• hematologic disease

• anticoagulant medication

• preoperative hemoglobin < 10 g/dl

• preoperative transfusion of red blood cells

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Avascular Necrosis of Hip

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyounggi

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	postoperative bleeding volume		at first postoperative day	No
Primary	Hemoglobin		preoperative 1 day and postoperative 1 day	No
Primary	hematocrit		preoperative 1 day and postoperative 1 day	No
Primary	platelet		preoperative 1 day and postoperative 1 day	No
Primary	prothrombin time_international normalized ratio		preoperative 1 day and postoperative 1 day	No
Primary	activated partial prothrombin time		preoperative 1 day and postoperative 1 day	No
Primary	fibrinogen concentration		preoperative 1 day and postoperative 1 day	No
Primary	Rotational thromboelastometry		preoperative 1 day and postoperative 1 day	No
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 operaiton, an expected average of 3 hours)	No
Secondary	intraoperative urine output		Period from starting to finishing the operation (During operaiton, an expected average of 3 hours)	No
Secondary	transfusion units	Red blood cell	Period from starting to finishing the operation (During operaiton, an expected average of 3 hours) and postoperative first day	No