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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

Tracking Information
First Submitted Date  ICMJE July 28, 2016
First Posted Date  ICMJE August 9, 2016
Last Update Posted Date July 27, 2017
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2017)
Total blood loss on the post-operative day 1 [ Time Frame: 1 day post-operation ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2016)
  • Haemoglobin (Hb) [ Time Frame: 1 month ]
  • Hematocrit (Hct) [ Time Frame: 1 month ]
  • Platelets (PLT) [ Time Frame: 1 month ]
  • Prothrombin Time (PT) [ Time Frame: 1 month ]
  • International Normalized Ratio (INR) [ Time Frame: 1 month ]
  • Blood loss [ Time Frame: 1 month ]
    Hidden and external blood loss.
  • Post-operation drainage blood loss [ Time Frame: 3 days ]
  • Number of deep vein thrombosis cases [ Time Frame: 3 months ]
  • Number of pulmonary embolism cases [ Time Frame: 3 months ]
  • Number of transfusion cases [ Time Frame: 1 month ]
    Number of transfusion cases, number of units transfused and amount of transfusion
  • A partial thromboplastin time (APTT) [ Time Frame: 1 month ]
  • D-Dimer [ Time Frame: 1 month ]
  • Number of plexus venosus leg muscle thrombosis [ Time Frame: 3 months ]
  • Preoperation, intraoperation and post-operation R value (min) of thrombelastogram [ Time Frame: Preoperation, intraoperation and up to 1 week post-operation ]
  • Preoperation, intraoperation and post-operation K value (min) of thrombelastogram [ Time Frame: Preoperation, intraoperation and up to 1 week post-operation ]
  • Preoperation, intraoperation and post-operation α Angle (deg) of thrombelastogram [ Time Frame: Preoperation, intraoperation and up to 1 week post-operation ]
  • Preoperation, intraoperation and post-operation MA (mm) of thrombelastogram [ Time Frame: Preoperation, intraoperation and up to 1 week post-operation ]
  • Preoperation, intraoperation and post-operation EPL(%) of thrombelastogram [ Time Frame: Preoperation, intraoperation and up to 1 week post-operation ]
  • Preoperation, intraoperation and post-operation comprehensive index of blood clotting (CI) of thrombelastogram [ Time Frame: Preoperation, intraoperation and up to 1 week post-operation ]
    -3 ~ 3
  • Preoperation, intraoperation and post-operation LY30 (%) of thrombelastogram [ Time Frame: Preoperation, intraoperation and up to 1 week post-operation ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2017)
  • Haemoglobin (Hb) [ Time Frame: 7 day ]
    g/L
  • Hematocrit (Hct) [ Time Frame: 7 day ]
    Percentage
  • Blood platelet count (PLT) [ Time Frame: 7 day ]
  • Post-operation Hospital for special surgery score (HSS) [ Time Frame: 3 months ]
    Scoring
  • 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
  • Length of hospital stay (days) [ Time Frame: 3 months ]
    Days
  • Number of patients with infection [ Time Frame: 3 months ]
    Post-operatively
  • Number of deep vein thrombosis (DVT) cases [ Time Frame: 1 month ]
    Post-operatively
  • Number of pulmonary embolism (PE) cases [ Time Frame: 1 month ]
    Post-operatively
  • Intraoperative blood loss [ Time Frame: 3 hours ]
    Post-operatively
  • Intravenous fluid administration on the operation day [ Time Frame: 1 day ]
    Milliliter
  • Total blood loss on the post-operative day 3 [ Time Frame: 3 day post-operation ]
    Milliliter
  • Reaction time (R-time) [ Time Frame: 24 hours ]
  • Rate of thrombus formation (K time) [ Time Frame: 24 hours ]
  • Maximum amplitude (MA) [ Time Frame: 24 hours ]
  • Rate of thrombus formation (α-angle) [ Time Frame: 24 hours ]
  • Lysis rate at 30 min (LY30) [ Time Frame: 24 hours ]
  • Coagulation index (CI) [ Time Frame: 24 hours ]
  • Interleukin(IL)-1β [ Time Frame: 24 hours ]
  • Interleukin(IL)-6 [ Time Frame: 24 hours ]
  • Interleukin(IL)-8 [ Time Frame: 24 hours ]
  • Tumor necrosis factor (TNF)-α [ Time Frame: 24 hours ]
  • C-reactive protein (CRP) [ Time Frame: 24 hours ]
  • Interleukin(IL)-10 [ Time Frame: 24 hours ]
  • Wound score [ Time Frame: 14 day ]
  • Blood transfusion rate [ Time Frame: 7 day ]
  • Blood transfusion volume (mL) [ Time Frame: 7 day ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2016)
  • Tourniquet time during operation [ Time Frame: 1 day ]
  • Preoperative and post-operation Visual Analogue Scale (VAS) pain score [ Time Frame: Through study completion, an average of 3 months ]
    There is only one Unit of Measure for VAS pain score, that is 0-10 points.
  • Preoperative and post-operation Western Ontario and McMaster Universities Arthritis Index (WOMAC) score [ Time Frame: Through study completion, an average of 3 months ]
    There is only one Unit of Measure for WOMAC score, it contains pain score, stiffness score and function score, then we will have a comprehensive score for hip or knee joint, the unit of WOMAC score is point
  • Preoperative and post-operation American knee society knee score (KSS) [ Time Frame: Through study completion, an average of 3 months ]
    There is only one Unit of Measure for KSS score, it is point
  • Preoperative and post-operation range of motion (ROM) of operated knee joint [ Time Frame: Through study completion, an average of 3 months ]
    There is only one Unit of Measure for ROM, it is degree
  • Length of hospital stay [ Time Frame: 3 months ]
  • Number of patients with infection [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Versus Topical Administration of Low Dose Epinephrine Plus Combined Administration of Intravenous and Topical Tranexamic Acid (TXA)for Primary Total Knee Arthroplasty
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Blood Loss
Intervention  ICMJE
  • Drug: Tranexamic acid (TXA)
    IV and topical administration
  • Drug: Epinephrine
Study Arms  ICMJE
  • Experimental: Intravenous epinephrine
    Intravenous (IV) low dose epinephrine
    Interventions:
    • Drug: Tranexamic acid (TXA)
    • Drug: Epinephrine
  • Experimental: Topical epinephrine
    Topical epinephrine
    Interventions:
    • Drug: Tranexamic acid (TXA)
    • Drug: Epinephrine
  • Active Comparator: Control
    No epinephrine
    Intervention: Drug: Tranexamic acid (TXA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 8, 2016)
210
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02860221
Other Study ID Numbers  ICMJE Knee blood
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Liu Yang, Southwest Hospital, China
Study Sponsor  ICMJE Southwest Hospital, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Southwest Hospital, China
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP