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Intravenous Versus Topical Administration of Low Dose Epinephrine Plus Combined Administration of Intravenous and Topical Tranexamic Acid (TXA)for Primary Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02860221
Recruitment Status : Unknown
Verified July 2017 by Liu Yang, Southwest Hospital, China.
Recruitment status was:  Recruiting
First Posted : August 9, 2016
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Liu Yang, Southwest Hospital, China

Brief Summary:
The purpose of this study is to compare the blood loss of intravenous and topical administration of low dose epinephrine plus combined administration of intravenous and topical tranexamic acid for primary total knee arthroplasty.

Condition or disease Intervention/treatment Phase
Blood Loss Drug: Tranexamic acid (TXA) Drug: Epinephrine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2015
Estimated Primary Completion Date : July 2017
Study Completion Date : July 2017


Arm Intervention/treatment
Experimental: Intravenous epinephrine
Intravenous (IV) low dose epinephrine
Drug: Tranexamic acid (TXA)
IV and topical administration

Drug: Epinephrine
Experimental: Topical epinephrine
Topical epinephrine
Drug: Tranexamic acid (TXA)
IV and topical administration

Drug: Epinephrine
Active Comparator: Control
No epinephrine
Drug: Tranexamic acid (TXA)
IV and topical administration




Primary Outcome Measures :
  1. Total blood loss on the post-operative day 1 [ Time Frame: 1 day post-operation ]

Secondary Outcome Measures :
  1. Haemoglobin (Hb) [ Time Frame: 7 day ]
    g/L

  2. Hematocrit (Hct) [ Time Frame: 7 day ]
    Percentage

  3. Blood platelet count (PLT) [ Time Frame: 7 day ]
  4. Post-operation Hospital for special surgery score (HSS) [ Time Frame: 3 months ]
    Scoring

  5. Preoperative and post-operation range of motion (ROM) of operated knee joint (degree) [ Time Frame: Through study completion, an average of 3 months ]
    There is only one Unit of Measure for ROM, it is degree

  6. Length of hospital stay (days) [ Time Frame: 3 months ]
    Days

  7. Number of patients with infection [ Time Frame: 3 months ]
    Post-operatively

  8. Number of deep vein thrombosis (DVT) cases [ Time Frame: 1 month ]
    Post-operatively

  9. Number of pulmonary embolism (PE) cases [ Time Frame: 1 month ]
    Post-operatively

  10. Intraoperative blood loss [ Time Frame: 3 hours ]
    Post-operatively

  11. Intravenous fluid administration on the operation day [ Time Frame: 1 day ]
    Milliliter

  12. Total blood loss on the post-operative day 3 [ Time Frame: 3 day post-operation ]
    Milliliter

  13. Reaction time (R-time) [ Time Frame: 24 hours ]
  14. Rate of thrombus formation (K time) [ Time Frame: 24 hours ]
  15. Maximum amplitude (MA) [ Time Frame: 24 hours ]
  16. Rate of thrombus formation (α-angle) [ Time Frame: 24 hours ]
  17. Lysis rate at 30 min (LY30) [ Time Frame: 24 hours ]
  18. Coagulation index (CI) [ Time Frame: 24 hours ]
  19. Interleukin(IL)-1β [ Time Frame: 24 hours ]
  20. Interleukin(IL)-6 [ Time Frame: 24 hours ]
  21. Interleukin(IL)-8 [ Time Frame: 24 hours ]
  22. Tumor necrosis factor (TNF)-α [ Time Frame: 24 hours ]
  23. C-reactive protein (CRP) [ Time Frame: 24 hours ]
  24. Interleukin(IL)-10 [ Time Frame: 24 hours ]
  25. Wound score [ Time Frame: 14 day ]
  26. Blood transfusion rate [ Time Frame: 7 day ]
  27. Blood transfusion volume (mL) [ Time Frame: 7 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients between the ages of 20 and 75 who were diagnosed with osteoarthritis of the knee and scheduled for an elective primary total knee arthroplasty and those who were willing and able to return for follow-up over at least a 6-month postoperative period

Exclusion Criteria:

  • Acute coronary syndrome < 6 months
  • Glaucoma,pheochromocytoma, thyrotoxicosis, digoxin intoxication, serum potassium < 3.0 mmol, alcohol abuse, premenopausal women
  • Current treatment with adenosine diphosphate (ADP) receptor antagonists, Factor Xa or thrombin inhibitors,heparin (excluding Low Molecular Weight Heparin (LMWH) for perioperative thromboprophylaxis), tricyclic antidepressants, or monoamine oxidase(MAO) or Catechol-O-methyltransferase (COMT) inhibitors
  • Patients with history of thromboembolic disease, bleeding disorder
  • Patients with history of renal impairment, cardiovascular diseases (previous myocardial infarction, atrial fibrillation) or cerebrovascular conditions (previous stroke or peripheral vascular surgery)
  • Allergy to TXA

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): NCT02860221


Locations
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China, Chongqing
Southwest Hospital Recruiting
Chongqing, Chongqing, China, 400038
Contact: Weinan Zeng, doctor    +8615023100103    weinanzeng@163.com   
Sponsors and Collaborators
Southwest Hospital, China
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Responsible Party: Liu Yang, Professor, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT02860221    
Other Study ID Numbers: Knee blood
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Liu Yang, Southwest Hospital, China:
Arthroplasty, Replacement, Knee
Epinephrine
Tranexamic acid
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Epinephrine
Tranexamic Acid
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants