Trial record 3 of 7 for: "Exsanguination"

Previous Study | Return to List | Next Study

Comparison of Topical Versus Intravenous Tranexamic Acid in TKA

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified March 2015 by zhoukaidi, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

zhoukaidi, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT02393300

First received: March 15, 2015

Last updated: March 25, 2015

Last verified: March 2015

History of Changes

Purpose

Previous studies in both the cardiovascular and orthopedic study have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate largely without major complications . In addition, many meta-analyses have confirmed these results . However, there is little information about comparison among the different routes of TXA administration in TKA. Therefore, this study has been designed to determine which administration route of TXA is more effective and safety.

Condition	Intervention	Phase
Total Blood Loss	Drug: normal saline Drug: Tranexamic Acid	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment
Official Title:	Comparison of Topical Versus Intravenous Tranexamic Acid in Primary Total Knee Arthroplasty：A Prospective Randomized Study

Resource links provided by NLM:

Drug Information available for: Tranexamic acid

U.S. FDA Resources

Further study details as provided by zhoukaidi, Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:

Total Blood Loss（TBL） [ Time Frame: calculated by an equation at the fifth postoperative day ]
Total Blood Loss（TBL） was calculated with equations described by Gross et al.

Secondary Outcome Measures:

Transfusion rates [ Time Frame: from the day of surgery to the day of discharge,an expected average of 7 days ]
Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, over the course of the patient's hospital stay

Other Outcome Measures:

Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary [ Time Frame: twelve weeks after surgery ]
Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism
other thromboembolic event [ Time Frame: twelve weeks after surgery ]
Clinically proven Acute Myocardial Infarction、acute kidney infarction or cerebral infarction
drainage output [ Time Frame: it will be recorded at the first day and the second day after surgery ]
human serum albumin usage [ Time Frame: from the day of surgery to the day of discharge,an expected average of 7 days ]
the investigators will record the dosage of the human blood albumin used in each patient.
American Society of Anesthesiologists Physical Status Classification (ASA class) [ Time Frame: at the day of surgery ]
Disseminated Intravascular Coagulation（DIC） [ Time Frame: at any day before surgery and the first the fifth day after surgery ]


Estimated Enrollment:	150
Study Start Date:	September 2014
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Group1 60 Milliliters（ml）Normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away.	Drug: normal saline The normal saline solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet. Other Name: 0.9% sodium chloride
Experimental: Group2 two-dose intravenous tranexamic acid will be applied as follow: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride),the first dose 15' before the tourniquet deflation and the second dose at 180' after the first dosage	Drug: Tranexamic Acid The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the circuit nurse and the circuit nurse will ask the anesthetist to apply the solution intravenously before tourniquet deflation. The dosage and applying route can also be looked up in doctor's order sheet. Other Name: Cyclokapron
Experimental: Group 3 3g Tranexamic Acid diluted to 60 Milliliters（ml） with normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away.	Drug: Tranexamic Acid The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet. Other Name: Cyclokapron

Detailed Description:

Objectives:To assess the efficacy and safety between the two different applying routes.

Patients in this project will be randomly divided into three groups , one group is a blank group and the rest two receive either the topical or the intravenous form of tranexamic acid during unilateral TKA(total knee arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction events will be recorded to assess the safety of the tranexamic acid during a six-week follow-up for each patient.

All surgery are under general anesthesia, through direct lateral approach with cementless prosthesis.For all patients, the drain tube will be clamped and closed completely for 2 hours; then the clamp will be fully opened.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Consented to join in our project.
Adult patients (greater than 18 years old)
Patients scheduled for primary unilateral knee arthroplasty

Exclusion Criteria:

Patients who refuse to sign the Inform Consent
Had an allergy to TXA.
Using anticoagulant drugs within a week.
Coagulopathy (preoperative platelet count <150,000/mm3,International Sensitivity Index（INR）>1.4, prolonged Activated Partial Thromboplastin Time，Prothrombin Time ，or thrombin time >1.4 times longer than normal.
Breastfeeding
Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; renal dysfunction ( glomerular filtration rate<60); or hepatic disfunction(glutamic-pyruvic transaminase>80 or glutamic oxalacetic transaminase>80).Retinopathy (disturbances of color vision).

9.History of thromboembolic disease

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02393300

Contacts


Contact: kaidi zhou, master	+86-18916535803	zhoukaidi198983@126.com
Contact: jianmin feng, master	+86-18917762523	fengjm@shtel.net.cn

Locations


China, Shanghai
Orthopedic Department of Ruijin hospital	Recruiting
Shanghai, Shanghai, China, 200001
Contact: kaidi zhou, MD +86-18916535803 zhoukaidi198983@126.com
Contact: jianmin feng, MD +86-18917762523 fengjm@shtel.net.cn

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

Investigators


Principal Investigator:	jianmin feng, master	ruijin hospital，shanghai

More Information


Responsible Party:	zhoukaidi, MD in Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:	NCT02393300 History of Changes
Other Study ID Numbers:	JTU-GK-011
Study First Received:	March 15, 2015
Last Updated:	March 25, 2015

Keywords provided by zhoukaidi, Shanghai Jiao Tong University School of Medicine:


tranexamic acid blood loss topical administration intravenous administration

Additional relevant MeSH terms:


Hemorrhage Exsanguination Pathologic Processes Tranexamic Acid Antifibrinolytic Agents	Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants

ClinicalTrials.gov processed this record on July 13, 2017

To Top