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

NCT03867214 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: XJODCT2014003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis; Pneumonia

Outcome Measures

Primary Outcomes (1)

• Rate of Allogeneic Blood Transfusion as a Measure of Efficacy

  one week after surgery

Study Arms (2)

Experimental

EXPERIMENTAL

Receiving TXA, Study group Tranexamic acid, Study group tranexamic acid 1g, intravenous injection, pre-operationally

Drug: Glutamine

Placebo Comparator

PLACEBO COMPARATOR

Normal saline, Control group Not receiving tranexamic acid, Control group Normal saline 100mL, intravenous injection, pre-operationally

Drug: Normal saline

Interventions

Glutamine DRUG

1 g of tranexamic acid in 100 mL of normal saline intravenously approximately 15 minutes before incision

Experimental

Normal saline DRUG

100 mL of normal saline intravenously approximately 15 minutes before incision

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[\>1.4 times normal\]).

Sponsors & Collaborators

• Yanzhao: lead

Study Sites (1)

Xijing Hospital

Xi'an, China

RECRUITING

MeSH Terms

Conditions

Stomatitis; Pneumonia

Interventions

Glutamine; Saline Solution

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Qingsheng Zhu

  Air Force Military Medical University, China

  STUDY DIRECTOR

Central Study Contacts

Zhao Yan, MD

CONTACT

+86-29-84775280; yanzhaoii@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 7, 2019
• Study Start: January 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2024
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)