Avascular Necrosis of Femoral Head Clinical Trial
Official title:
The Effect of Tranexamic Acid on Blood Coagulation After Colloid Infusion During Surgery: Rotational Thromboelastography Measurement
| Verified date | May 2014 |
| Source | Seoul National University Bundang Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Gyeonggi |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Bundang Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rotational thromboelastography | 30 minutes before starting an operation and 30 minutes after finishing an operation | No | |
| Secondary | Hemoglobin | 30 minutes before starting an operation and 30 minutes after finishing an operation | No | |
| Secondary | Platelet | 30 minutes before starting an operation and 30 minutes after finishing an operation | No | |
| Secondary | International normalized ratio of prothrombin time | 30 minutes before starting an operation and 30 minutes after finishing an operation | No | |
| Secondary | Activated partial thromboplastin time | 30 minutes before starting an operation and 30 minutes after finishing an operation | No | |
| Secondary | Fibrinogen | 30 minutes before starting an operation and 30 minutes after finishing an operation | No |
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