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The Effects of Low-dose Epinephrine Plus Tranexamic Acid on Perioperative Haemostasis and Inflammatory Reaction in Major Surgery

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ClinicalTrials.gov Identifier: NCT02864095
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : July 31, 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 hip arthroplasty.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 : October 2017
Estimated Study Completion Date : October 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. Blood loss on post-operative day 1 [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 1 months ]
  2. Number of patients with infection [ Time Frame: 1 months ]
  3. Number of deep vein thrombosis cases [ Time Frame: 1 months ]
  4. Number of pulmonary embolism cases [ Time Frame: 1 months ]
  5. Number of plexus venosus leg muscle thrombosis [ Time Frame: 1 months ]
  6. Serum levels of IL-10(Preoperation, intraoperation and post-operation) [ Time Frame: Preoperation, intraoperation and up to 2 days post-operation ]
  7. Serum levels of IL-6(Preoperation, intraoperation and post-operation) [ Time Frame: Preoperation, intraoperation and up to 2 days post-operation ]
  8. Serum levels of IL-1β(Preoperation, intraoperation and post-operation) [ Time Frame: Preoperation, intraoperation and up to 2 days post-operation ]
  9. Serum levels of TNF-α(Preoperation, intraoperation and post-operation) [ Time Frame: Preoperation, intraoperation and up to 2 days post-operation ]
  10. Haemoglobin (Hb) [ Time Frame: 7 days ]
  11. Hematocrit (Hct) [ Time Frame: 7 days ]
  12. Platelets (PLT) [ Time Frame: 7 days ]
  13. Blood loss on post-operative day 3 [ Time Frame: 3 days ]
  14. Preoperation, intraoperation and post-operation R value (min) of thrombelastogram [ Time Frame: Preoperation, intraoperation and up to 2 days post-operation ]
  15. Preoperation, intraoperation and post-operation K value (min) of thrombelastogram [ Time Frame: Preoperation, intraoperation and up to 2 days post-operation ]
  16. Preoperation, intraoperation and post-operation Angle (deg) of thrombelastogram [ Time Frame: Preoperation, intraoperation and up to 2 days post-operation ]
  17. Preoperation, intraoperation and post-operation MA (mm) of thrombelastogram [ Time Frame: Preoperation, intraoperation and up to 2 days post-operation ]
  18. Preoperation, intraoperation and post-operation comprehensive index of blood clotting (CI) of thrombelastogram [ Time Frame: Preoperation, intraoperation and up to 2 days post-operation ]
  19. Preoperation, intraoperation and post-operation LY30 (%) of thrombelastogram [ Time Frame: Preoperation, intraoperation and up to 2 days post-operation ]
  20. Number of patients with blood transfusion [ Time Frame: 7 days ]
    Number of transfusion cases, number of units transfused and amount of transfusion



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Ages Eligible for Study:   18 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 as having osteoarthritis or osteonecrosis of the femoral head
  • Scheduled for an elective primary total hip arthroplasty
  • 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): NCT02864095


Locations
China, Chongqing
Southwest Hospital Recruiting
Chongqing, Chongqing, China, 400038
Contact: Weinan Zeng, doctor    +8615023100103    weinanzeng@163.com   
Sponsors and Collaborators
Southwest Hospital, China

Responsible Party: Liu Yang, Professor, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT02864095     History of Changes
Other Study ID Numbers: Hip blood
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Liu Yang, Southwest Hospital, China:
Arthroplasty, Replacement, Hip
Epinephrine
Tranexamic acid

Additional relevant MeSH terms:
Epinephrine
Racepinephrine
Epinephryl borate
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