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Rotational Thromboelastography Study in Tranexamic Acid and Colloid Infusion

Primary Purpose

Avascular Necrosis of Femoral Head, Degenerative Arthritis of Hip

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Avascular Necrosis of Femoral Head

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing total hip replacement arthroplasty, who are diagnosed with the avascular necrosis of femoral head or degenerative arthritis of hip
  • American Society of Anesthesiologist I or II

Exclusion Criteria:

  • Patients receiving an intraoperative transfusion
  • Patients receiving thrombin
  • Patients having venous thromboembolism
  • Patients having renal or hepatic disease
  • Patients having coagulopathy
  • Patient having heart failure

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Colloid

Tranexamic acid

Arm Description

During the operation, Lactate Ringer's solution is used as the maintenance fluid, and colloid is infused for the compensation of the intraoperative blood loss.

During the operation, Lactate Ringer's solution is used as the maintenance fluid, and colloid is infused for the compensation of the intraoperative blood loss. In addition, 1 g of tranexamic acid in 100 ml normal saline is administered intravenously over 30 min after finishing the procedure of hip implant insertion.

Outcomes

Primary Outcome Measures

Rotational thromboelastography

Secondary Outcome Measures

Hemoglobin
Platelet
International normalized ratio of prothrombin time
Activated partial thromboplastin time
Fibrinogen

Full Information

First Posted
May 21, 2014
Last Updated
June 16, 2015
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02146456
Brief Title
Rotational Thromboelastography Study in Tranexamic Acid and Colloid Infusion
Official Title
The Effect of Tranexamic Acid on Blood Coagulation After Colloid Infusion During Surgery: Rotational Thromboelastography Measurement
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

5. Study Description

Brief Summary
Colloid solution is generally used to maintain intravascular volume. It is reported to impair blood coagulation in vivo and in vitro more than crystalloid does by prolonging coagulation time and decreasing clot strength. The formed fibrin clot is more vulnerable for fibrinolysis in a case of using colloid. Dilution of plasmin in vitro with colloid enhances fibrinolysis primarily by diminishing α2-antiplasmin-plasmin interaction. Tranexamic acid is an antifibrinolytics that competitively inhibits the activation of plasminogen, by binding to specific site of both plasminogen and plasmin, a molecule responsible for the degradation of fibrin, a protein that forms the framework of blood clot. It is used to treat or prevent excessive blood loss during surgery and in other medical conditions. Gastrointestinal effect, dizziness, fatigue, headache, hypersensitivity reaction, or potential risk of thrombosis is reported as the adverse effect of tranexamic acid. We hypothesized that inhibition of plasmin by tranexamic acid after colloid administration can improve the colloid-induced clot strength impairment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avascular Necrosis of Femoral Head, Degenerative Arthritis of Hip

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colloid
Arm Type
No Intervention
Arm Description
During the operation, Lactate Ringer's solution is used as the maintenance fluid, and colloid is infused for the compensation of the intraoperative blood loss.
Arm Title
Tranexamic acid
Arm Type
Experimental
Arm Description
During the operation, Lactate Ringer's solution is used as the maintenance fluid, and colloid is infused for the compensation of the intraoperative blood loss. In addition, 1 g of tranexamic acid in 100 ml normal saline is administered intravenously over 30 min after finishing the procedure of hip implant insertion.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Primary Outcome Measure Information:
Title
Rotational thromboelastography
Time Frame
30 minutes before starting an operation and 30 minutes after finishing an operation
Secondary Outcome Measure Information:
Title
Hemoglobin
Time Frame
30 minutes before starting an operation and 30 minutes after finishing an operation
Title
Platelet
Time Frame
30 minutes before starting an operation and 30 minutes after finishing an operation
Title
International normalized ratio of prothrombin time
Time Frame
30 minutes before starting an operation and 30 minutes after finishing an operation
Title
Activated partial thromboplastin time
Time Frame
30 minutes before starting an operation and 30 minutes after finishing an operation
Title
Fibrinogen
Time Frame
30 minutes before starting an operation and 30 minutes after finishing an operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing total hip replacement arthroplasty, who are diagnosed with the avascular necrosis of femoral head or degenerative arthritis of hip American Society of Anesthesiologist I or II Exclusion Criteria: Patients receiving an intraoperative transfusion Patients receiving thrombin Patients having venous thromboembolism Patients having renal or hepatic disease Patients having coagulopathy Patient having heart failure
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Rotational Thromboelastography Study in Tranexamic Acid and Colloid Infusion

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