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Trial record 14 of 30 for:    "Collagen Disease" | "Tranexamic Acid"

Rotational Thromboelastography Study in Tranexamic Acid and Colloid Infusion

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ClinicalTrials.gov Identifier: NCT02146456
Recruitment Status : Completed
First Posted : May 23, 2014
Last Update Posted : June 17, 2015
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital

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.


Condition or disease Intervention/treatment Phase
Avascular Necrosis of Femoral Head Degenerative Arthritis of Hip Drug: Tranexamic Acid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Tranexamic Acid on Blood Coagulation After Colloid Infusion During Surgery: Rotational Thromboelastography Measurement
Study Start Date : May 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

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Arm Intervention/treatment
No Intervention: Colloid
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.
Experimental: Tranexamic acid

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



Primary Outcome Measures :
  1. Rotational thromboelastography [ Time Frame: 30 minutes before starting an operation and 30 minutes after finishing an operation ]

Secondary Outcome Measures :
  1. Hemoglobin [ Time Frame: 30 minutes before starting an operation and 30 minutes after finishing an operation ]
  2. Platelet [ Time Frame: 30 minutes before starting an operation and 30 minutes after finishing an operation ]
  3. International normalized ratio of prothrombin time [ Time Frame: 30 minutes before starting an operation and 30 minutes after finishing an operation ]
  4. Activated partial thromboplastin time [ Time Frame: 30 minutes before starting an operation and 30 minutes after finishing an operation ]
  5. Fibrinogen [ Time Frame: 30 minutes before starting an operation and 30 minutes after finishing an operation ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146456


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital

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Responsible Party: Hyo-Seok Na, Pf, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02146456     History of Changes
Other Study ID Numbers: Colloid_tranexamic acid
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: June 17, 2015
Last Verified: May 2014
Additional relevant MeSH terms:
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Rheumatic Diseases
Tranexamic Acid
Osteoarthritis
Necrosis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants