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Status unknownNCT03867214Updated Apr 27, 2023

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

A Phase 4 interventional study of Glutamine and Normal saline in Oral Mucositis and Pneumonia, sponsored by Yanzhao. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-27.

Sponsored by Yanzhao · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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

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Conditions studied

  • Oral Mucositis
  • Pneumonia
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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 100 is close to the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

This is the only study on the registry with Yanzhao as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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]).
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • DrugGlutamine

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

  • DrugNormal saline

    100 mL of normal saline intravenously approximately 15 minutes before incision

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What researchers measure

Primary outcomes

  1. Rate of Allogeneic Blood Transfusion as a Measure of Efficacy

    Time frame: one week after surgery

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Study locations

1 of 1 sites recruiting
  • Xijing Hospital
    Xi'an, China
    • Chongfei Yang, M.D. · Contact
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03867214
Lead sponsor
Yanzhao
Responsible party
Yanzhao (Dr, Xijing Hospital) — Sponsor-investigator
First posted
Mar 7, 2019
Start date
Jan 1, 2019
Primary completion
Mar 1, 2021
Completion
Mar 1, 2024 (estimated)
Last update
Apr 27, 2023

Study contacts

Zhao Yan, MD
Contact
yanzhaoii@163.com
+86-29-84775280
Qingsheng Zhu
study director · Air Force Military Medical University, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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