Back to resultsIntravenous Versus Topical Administration of Low Dose Epinephrine Plus Combined Administration of Intravenous and Topical Tranexamic Acid (TXA)for Primary Total Knee Arthroplasty
Primary Purpose
Blood Loss
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tranexamic acid (TXA)
Epinephrine
Sponsored by
About this trial
This is an interventional treatment trial for Blood Loss focused on measuring Arthroplasty, Replacement, Knee, Epinephrine, Tranexamic acid
Eligibility 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
Sites / Locations
- Southwest HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Intravenous epinephrine
Topical epinephrine
Control
Arm Description
Intravenous (IV) low dose epinephrine
Topical epinephrine
No epinephrine
Outcomes
Primary Outcome Measures
Total blood loss on the post-operative day 1
Secondary Outcome Measures
Haemoglobin (Hb)
g/L
Hematocrit (Hct)
Percentage
Blood platelet count (PLT)
Post-operation Hospital for special surgery score (HSS)
Scoring
Preoperative and post-operation range of motion (ROM) of operated knee joint (degree)
There is only one Unit of Measure for ROM, it is degree
Length of hospital stay (days)
Days
Number of patients with infection
Post-operatively
Number of deep vein thrombosis (DVT) cases
Post-operatively
Number of pulmonary embolism (PE) cases
Post-operatively
Intraoperative blood loss
Post-operatively
Intravenous fluid administration on the operation day
Milliliter
Total blood loss on the post-operative day 3
Milliliter
Reaction time (R-time)
Rate of thrombus formation (K time)
Maximum amplitude (MA)
Rate of thrombus formation (α-angle)
Lysis rate at 30 min (LY30)
Coagulation index (CI)
Interleukin(IL)-1β
Interleukin(IL)-6
Interleukin(IL)-8
Tumor necrosis factor (TNF)-α
C-reactive protein (CRP)
Interleukin(IL)-10
Wound score
Blood transfusion rate
Blood transfusion volume (mL)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02860221
Brief Title
Intravenous Versus Topical Administration of Low Dose Epinephrine Plus Combined Administration of Intravenous and Topical Tranexamic Acid (TXA)for Primary Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
Keywords
Arthroplasty, Replacement, Knee, Epinephrine, Tranexamic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravenous epinephrine
Arm Type
Experimental
Arm Description
Intravenous (IV) low dose epinephrine
Arm Title
Topical epinephrine
Arm Type
Experimental
Arm Description
Topical epinephrine
Arm Title
Control
Arm Type
Active Comparator
Arm Description
No epinephrine
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid (TXA)
Intervention Description
IV and topical administration
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Primary Outcome Measure Information:
Title
Total blood loss on the post-operative day 1
Time Frame
1 day post-operation
Secondary Outcome Measure Information:
Title
Haemoglobin (Hb)
Description
g/L
Time Frame
7 day
Title
Hematocrit (Hct)
Description
Percentage
Time Frame
7 day
Title
Blood platelet count (PLT)
Time Frame
7 day
Title
Post-operation Hospital for special surgery score (HSS)
Description
Scoring
Time Frame
3 months
Title
Preoperative and post-operation range of motion (ROM) of operated knee joint (degree)
Description
There is only one Unit of Measure for ROM, it is degree
Time Frame
Through study completion, an average of 3 months
Title
Length of hospital stay (days)
Description
Days
Time Frame
3 months
Title
Number of patients with infection
Description
Post-operatively
Time Frame
3 months
Title
Number of deep vein thrombosis (DVT) cases
Description
Post-operatively
Time Frame
1 month
Title
Number of pulmonary embolism (PE) cases
Description
Post-operatively
Time Frame
1 month
Title
Intraoperative blood loss
Description
Post-operatively
Time Frame
3 hours
Title
Intravenous fluid administration on the operation day
Description
Milliliter
Time Frame
1 day
Title
Total blood loss on the post-operative day 3
Description
Milliliter
Time Frame
3 day post-operation
Title
Reaction time (R-time)
Time Frame
24 hours
Title
Rate of thrombus formation (K time)
Time Frame
24 hours
Title
Maximum amplitude (MA)
Time Frame
24 hours
Title
Rate of thrombus formation (α-angle)
Time Frame
24 hours
Title
Lysis rate at 30 min (LY30)
Time Frame
24 hours
Title
Coagulation index (CI)
Time Frame
24 hours
Title
Interleukin(IL)-1β
Time Frame
24 hours
Title
Interleukin(IL)-6
Time Frame
24 hours
Title
Interleukin(IL)-8
Time Frame
24 hours
Title
Tumor necrosis factor (TNF)-α
Time Frame
24 hours
Title
C-reactive protein (CRP)
Time Frame
24 hours
Title
Interleukin(IL)-10
Time Frame
24 hours
Title
Wound score
Time Frame
14 day
Title
Blood transfusion rate
Time Frame
7 day
Title
Blood transfusion volume (mL)
Time Frame
7 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weinan Zeng, doctor
Phone
+8615023100103
Email
weinanzeng@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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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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