NCT01512628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

1.9 years

First QC Date

January 9, 2012

Last Update Submit

January 26, 2014

Conditions

Avascular Necrosis of HipTotal Hip Replacement Arthroplasty

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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.

  • FIBTEM parameters change from preoperative values at post-operation

    maximum clot firmness (mm)

    30 min before and 30 min after operation

Secondary Outcomes (8)

  • Infused total fluid volume

    Participants will be followed for the duration of THRA operation in operating room, an expected average tiem of 3 hours

  • Hemoglobin

    30 minutes before operation and 30 minutes after operation

  • postoperative blood loss

    postoperative 1 day and 2 day

  • Hematocrit

    30 minutes before operation and 30 minutes after operation

  • Platelet

    30 minutes before operation and 30 minutes after operation

  • +3 more secondary outcomes

Study Arms (3)

PENTA group

ACTIVE COMPARATOR

Pentaspan is administered as a colloid.

Drug: Pentaspan, voluven, volulyte

voluVEN group

ACTIVE COMPARATOR

Voluven is administered as a colloid.

Drug: Pentaspan, voluven, volulyte

voluLYTE group

ACTIVE COMPARATOR

Volulyte is administered as a colloid.

Drug: Pentaspan, voluven, volulyte

Interventions

Pentaspan, voluven, volulyteDRUG

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

PENTA groupvoluLYTE groupvoluVEN group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • hematologic disease
  • anticoagulant medication
  • preoperative hemoglobin \< 10 g/dl
  • renal disease
  • pulmonary disease (pulmonary edema, effusion)
  • cardiovascular disease (coronary heart disease, congestive heart failure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Gyounggi, 463-707, South Korea

Location

MeSH Terms

Interventions

Hydroxyethyl Starch DerivativesHES 130-0.4

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 19, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

KR(1)