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

Yanzhao

Status and phase: Enrolling; Phase 4

Conditions: Oral Mucositis; Pneumonia

Treatments: Drug: Normal saline; Drug: Glutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03867214

XJODCT2014003

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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]).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

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

Treatment:

Drug: Glutamine

Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline