Effects of Oral Care With Glutamine on Oral Health, Oral Flora and Incidence of Pneumonia After Neurosurgery With Microbiome Analysis

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Oral Mucositis
• Intervention / Treatment: Drug: Normal saline; Drug: Glutamine

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zhao Yan, MD; Phone Number: +86-29-84775280; Email: yanzhaoii@163.com

Study Locations

• China
  • Xi'an, China
    • Recruiting
    • Xijing Hospital
    • Contact: Chongfei Yang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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]).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Receiving TXA, Study group Tranexamic acid, Study group tranexamic acid 1g, intravenous injection, pre-operationally	Drug: Glutamine; 1 g of tranexamic acid in 100 mL of normal saline intravenously approximately 15 minutes before incision
Placebo Comparator: Placebo Comparator; Normal saline, Control group Not receiving tranexamic acid, Control group Normal saline 100mL, intravenous injection, pre-operationally	Drug: Normal saline; 100 mL of normal saline intravenously approximately 15 minutes before incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of Allogeneic Blood Transfusion as a Measure of Efficacy	one week after surgery

Collaborators and Investigators

• Sponsor: Yanzhao
• Investigators: Study Director: Qingsheng Zhu, Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Pneumonia; Mucositis; Stomatitis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: XJODCT2014003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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