Back to resultsEffects of Oral Care With Glutamine on Oral Health, Oral Flora and Incidence of Pneumonia After Neurosurgery With Microbiome Analysis
Primary Purpose
Oral Mucositis, Pneumonia
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Glutamine
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Oral Mucositis
Eligibility Criteria
Inclusion Criteria:
- Adult patients who plan to undergo simultaneous primary total knee arthroplasty on bilateral knee joint with a diagnosis of osteoarthritis or aseptic bone necrosis, but not of rheumatoid arthritis;
- All patients who have normal preoperative platelet count, normal prothrombin time, normal partial thromboplastin time, and normal international normalized ratio;
- The use of only balanced electrolyte solutions and/or albumin for plasma volume restitution.
Exclusion Criteria:
- Allergy to tranexamic acid;
- Receiving warfarin or heparin; had a history of hemophilia, deep venous thrombosis, pulmonary embolism, or renal impairment; or were pregnant;
- Patients with any cardiovascular problems (such as myocardiac infarction history, atrial fibrillation, angina);
- Patients with thromboembolic disorders, or those exhibiting a deteriorating general condition;
- Preoperative anemia (a hemoglobin value of <11 g/dL in females and <12 g/dL in males), refusal of blood products;
- Preoperative use of anticoagulant therapy within five days before surgery, fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy (as identified by a preoperative platelet count of <150,000/mm3, an international normalized ratio of >1.4, or a prolonged partial thromboplastin time [>1.4 times normal]).
Sites / Locations
- Xijing HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Placebo Comparator
Arm Description
Receiving TXA, Study group Tranexamic acid, Study group tranexamic acid 1g, intravenous injection, pre-operationally
Normal saline, Control group Not receiving tranexamic acid, Control group Normal saline 100mL, intravenous injection, pre-operationally
Outcomes
Primary Outcome Measures
Rate of Allogeneic Blood Transfusion as a Measure of Efficacy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03867214
Brief Title
Effects of Oral Care With Glutamine on Oral Health, Oral Flora and Incidence of Pneumonia After Neurosurgery With Microbiome Analysis
Official Title
Effects of Oral Care With Glutamine on Oral Health, Oral Flora and Incidence of Pneumonia After Neurosurgery With Microbiome Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yanzhao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized, double-blind, single-center and controlled study comparing the efficacy and safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous bilateral total knee arthroplasty.
Detailed Description
A randomized, double-blind, single-center and controlled study comparing the efficacy and safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous bilateral total knee arthroplasty. Subjects will be monitored for occurrence of any complications, particularly deep venous thrombosis and thromboembolism during the hospital stay and for 1 months postoperatively
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis, Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Receiving TXA, Study group
Tranexamic acid, Study group tranexamic acid 1g,
intravenous injection, pre-operationally
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Normal saline, Control group
Not receiving tranexamic acid, Control group Normal
saline 100mL, intravenous injection, pre-operationally
Intervention Type
Drug
Intervention Name(s)
Glutamine
Intervention Description
1 g of tranexamic acid in 100 mL of normal saline intravenously approximately 15 minutes before incision
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
100 mL of normal saline intravenously approximately 15 minutes before incision
Primary Outcome Measure Information:
Title
Rate of Allogeneic Blood Transfusion as a Measure of Efficacy
Time Frame
one week after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients who plan to undergo simultaneous primary total knee arthroplasty on bilateral knee joint with a diagnosis of osteoarthritis or aseptic bone necrosis, but not of rheumatoid arthritis;
All patients who have normal preoperative platelet count, normal prothrombin time, normal partial thromboplastin time, and normal international normalized ratio;
The use of only balanced electrolyte solutions and/or albumin for plasma volume restitution.
Exclusion Criteria:
Allergy to tranexamic acid;
Receiving warfarin or heparin; had a history of hemophilia, deep venous thrombosis, pulmonary embolism, or renal impairment; or were pregnant;
Patients with any cardiovascular problems (such as myocardiac infarction history, atrial fibrillation, angina);
Patients with thromboembolic disorders, or those exhibiting a deteriorating general condition;
Preoperative anemia (a hemoglobin value of <11 g/dL in females and <12 g/dL in males), refusal of blood products;
Preoperative use of anticoagulant therapy within five days before surgery, fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy (as identified by a preoperative platelet count of <150,000/mm3, an international normalized ratio of >1.4, or a prolonged partial thromboplastin time [>1.4 times normal]).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhao Yan, MD
Phone
+86-29-84775280
Email
yanzhaoii@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingsheng Zhu
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Study Director
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chongfei Yang, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Oral Care With Glutamine on Oral Health, Oral Flora and Incidence of Pneumonia After Neurosurgery With Microbiome Analysis
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