Skip to content

Rotational Thromboelstometry (ROTEM) change_colloid_total Hip Replacement Arthroplasty

Hemostatic Changes After Colloid Fluid Administration During Total Hip Replacement Arthroplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01512628
Enrollment
75
Registered
2012-01-19
Start date
2012-01-31
Completion date
2013-12-31
Last updated
2014-01-28

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

Conditions

Avascular Necrosis of Hip, Total Hip Replacement Arthroplasty

Brief 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.

Interventions

DRUGPentaspan, voluven, volulyte

Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
INTEM parameters change from preoperative values at post-operation30 minutes before operation and 30 minutes after operationclotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)
EXTEM parameters change from preoperative values at post-operation30 minutes before and 30 minutes after operation.clotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)
FIBTEM parameters change from preoperative values at post-operation30 min before and 30 min after operationmaximum clot firmness (mm)

Secondary

MeasureTime frameDescription
Hematocrit30 minutes before operation and 30 minutes after operation
Platelet30 minutes before operation and 30 minutes after operation
Infused total fluid volumeParticipants will be followed for the duration of THRA operation in operating room, an expected average tiem of 3 hourscrystalloid and colloid
Activated Partial Thrombin Time30 minutes before operation and 30 minutes after operation
electrolytes30 minutes before operation and 30 minutes after operation
Prothrombin Time-Internatiolnal Normalized Ratio30 minutes before operation and 30 minutes after operation
Hemoglobin30 minutes before operation and 30 minutes after operation
postoperative blood losspostoperative 1 day and 2 day

Countries

South Korea

Outcome results

None listed

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