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

Primary Purpose

Blood Loss

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tranexamic acid (TXA)
Epinephrine
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss focused on measuring Arthroplasty, Replacement, Hip, Epinephrine, Tranexamic acid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Blood loss on post-operative day 1

Secondary Outcome Measures

Length of hospital stay
Number of patients with infection
Number of deep vein thrombosis cases
Number of pulmonary embolism cases
Number of plexus venosus leg muscle thrombosis
Serum levels of IL-10（Preoperation, intraoperation and post-operation）
Serum levels of IL-6（Preoperation, intraoperation and post-operation）
Serum levels of IL-1β（Preoperation, intraoperation and post-operation）
Serum levels of TNF-α（Preoperation, intraoperation and post-operation）
Haemoglobin (Hb)
Hematocrit (Hct)
Platelets (PLT)
Blood loss on post-operative day 3
Preoperation, intraoperation and post-operation R value (min) of thrombelastogram
Preoperation, intraoperation and post-operation K value (min) of thrombelastogram
Preoperation, intraoperation and post-operation Angle (deg) of thrombelastogram
Preoperation, intraoperation and post-operation MA (mm) of thrombelastogram
Preoperation, intraoperation and post-operation comprehensive index of blood clotting (CI) of thrombelastogram
Preoperation, intraoperation and post-operation LY30 (%) of thrombelastogram
Number of patients with blood transfusion
Number of transfusion cases, number of units transfused and amount of transfusion

Full Information

First Posted
July 28, 2016
Last Updated
July 26, 2017
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02864095
Brief Title
The Effects of Low-dose Epinephrine Plus Tranexamic Acid on Perioperative Haemostasis and Inflammatory Reaction in Major Surgery
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
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

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 hip 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, Hip, Epinephrine, Tranexamic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (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
Blood loss on post-operative day 1
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
1 months
Title
Number of patients with infection
Time Frame
1 months
Title
Number of deep vein thrombosis cases
Time Frame
1 months
Title
Number of pulmonary embolism cases
Time Frame
1 months
Title
Number of plexus venosus leg muscle thrombosis
Time Frame
1 months
Title
Serum levels of IL-10（Preoperation, intraoperation and post-operation）
Time Frame
Preoperation, intraoperation and up to 2 days post-operation
Title
Serum levels of IL-6（Preoperation, intraoperation and post-operation）
Time Frame
Preoperation, intraoperation and up to 2 days post-operation
Title
Serum levels of IL-1β（Preoperation, intraoperation and post-operation）
Time Frame
Preoperation, intraoperation and up to 2 days post-operation
Title
Serum levels of TNF-α（Preoperation, intraoperation and post-operation）
Time Frame
Preoperation, intraoperation and up to 2 days post-operation
Title
Haemoglobin (Hb)
Time Frame
7 days
Title
Hematocrit (Hct)
Time Frame
7 days
Title
Platelets (PLT)
Time Frame
7 days
Title
Blood loss on post-operative day 3
Time Frame
3 days
Title
Preoperation, intraoperation and post-operation R value (min) of thrombelastogram
Time Frame
Preoperation, intraoperation and up to 2 days post-operation
Title
Preoperation, intraoperation and post-operation K value (min) of thrombelastogram
Time Frame
Preoperation, intraoperation and up to 2 days post-operation
Title
Preoperation, intraoperation and post-operation Angle (deg) of thrombelastogram
Time Frame
Preoperation, intraoperation and up to 2 days post-operation
Title
Preoperation, intraoperation and post-operation MA (mm) of thrombelastogram
Time Frame
Preoperation, intraoperation and up to 2 days post-operation
Title
Preoperation, intraoperation and post-operation comprehensive index of blood clotting (CI) of thrombelastogram
Time Frame
Preoperation, intraoperation and up to 2 days post-operation
Title
Preoperation, intraoperation and post-operation LY30 (%) of thrombelastogram
Time Frame
Preoperation, intraoperation and up to 2 days post-operation
Title
Number of patients with blood transfusion
Description
Number of transfusion cases, number of units transfused and amount of transfusion
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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 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
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
Undecided

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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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