Rotational Thromboelstometry (ROTEM) change_colloid_total Hip Replacement Arthroplasty

Avascular Necrosis of Hip Clinical Trial

Official title:

Hemostatic Changes After Colloid Fluid Administration During Total Hip Replacement Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512628
• Other study ID #: B1111-140-010
• Status: Completed
• Phase: N/A
• First received: January 9, 2012
• Last updated: January 26, 2014
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators administered different kinds of colloids before transfusion of red blood cell to patient undergoing total hip replacement arthroplasty. The investigators will compare the differences of changes in rotational thromboelastometry (ROTEM) data among them.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed as avascular necrosis of hip and undergoing total hip replacement arthroplasty

Exclusion Criteria:

• hematologic disease

• anticoagulant medication

• preoperative hemoglobin < 10 g/dl

• renal disease

• pulmonary disease (pulmonary edema, effusion)

• cardiovascular disease (coronary heart disease, congestive heart failure)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Avascular Necrosis of Hip
• Total Hip Replacement Arthroplasty

Intervention

Drug:
• Pentaspan, voluven, volulyte
Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.

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	INTEM parameters change from preoperative values at post-operation	clotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)	30 minutes before operation and 30 minutes after operation	No
Primary	EXTEM parameters change from preoperative values at post-operation	clotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)	30 minutes before and 30 minutes after operation.	No
Primary	FIBTEM parameters change from preoperative values at post-operation	maximum clot firmness (mm)	30 min before and 30 min after operation	No
Secondary	Infused total fluid volume	crystalloid and colloid	Participants will be followed for the duration of THRA operation in operating room, an expected average tiem of 3 hours	No
Secondary	Hemoglobin		30 minutes before operation and 30 minutes after operation	No
Secondary	postoperative blood loss		postoperative 1 day and 2 day	No
Secondary	Hematocrit		30 minutes before operation and 30 minutes after operation	No
Secondary	Platelet		30 minutes before operation and 30 minutes after operation	No
Secondary	Prothrombin Time-Internatiolnal Normalized Ratio		30 minutes before operation and 30 minutes after operation	No
Secondary	Activated Partial Thrombin Time		30 minutes before operation and 30 minutes after operation	No
Secondary	electrolytes		30 minutes before operation and 30 minutes after operation	No