NCT02146456

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

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

May 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 17, 2015

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

May 21, 2014

Last Update Submit

June 16, 2015

Conditions

Avascular Necrosis of Femoral HeadDegenerative Arthritis of Hip

Outcome Measures

Primary Outcomes (1)

  • Rotational thromboelastography

    30 minutes before starting an operation and 30 minutes after finishing an operation

Secondary Outcomes (5)

  • Hemoglobin

    30 minutes before starting an operation and 30 minutes after finishing an operation

  • Platelet

    30 minutes before starting an operation and 30 minutes after finishing an operation

  • International normalized ratio of prothrombin time

    30 minutes before starting an operation and 30 minutes after finishing an operation

  • Activated partial thromboplastin time

    30 minutes before starting an operation and 30 minutes after finishing an operation

  • Fibrinogen

    30 minutes before starting an operation and 30 minutes after finishing an operation

Study Arms (2)

Colloid

NO INTERVENTION

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.

Tranexamic acid

EXPERIMENTAL

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.

Drug: Tranexamic Acid

Interventions

Tranexamic AcidDRUG
Tranexamic acid

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Femur Head Necrosis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

OsteonecrosisBone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pf

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 23, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 17, 2015

Record last verified: 2014-05

Locations

KR(1)