Clinical trial

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

Name

XJODCT2014003

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.

Trial arms

Trial start

2019-01-01

Estimated PCD

2021-03-01

Trial end

2024-03-01

Status

Recruiting

Phase

Early phase I

Treatment

Glutamine

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

Arms:

Experimental

Normal saline

100 mL of normal saline intravenously approximately 15 minutes before incision

Arms:

Placebo Comparator

Size

100

Primary endpoint

Rate of Allogeneic Blood Transfusion as a Measure of Efficacy

one week after surgery

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 \[\>1.4 times normal\]).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-04-27

1 organization

1 product

1 drug

2 indications

Organization

Product

Indication

Indication

Drug