The Efficacy and Safety of Using Tranexamic Acid by Different Means to Reduce Blood Loss During Total Knee Replacement

NCT02117128 | Completed Phase 4 DMC

• 1 other identifier: XJODCT2014001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

We will investigate the efficacy and safety of using tranexamic acid by intravenous, intra-articular and combinational administration to reduce blood loss during total knee replacement. We hypothesize a combined intra-articular and single intravenous dose protocol of tranexamic acid may achieve a higher therapeutic concentration at the intra-articular and extra-articular bleeding site with little or no systemic absorption and subsequent systemic side effects.

Conditions

Blood Loss

Keywords

Tranexamic Acid; Antifibrinolytic; Blood transfusion; Total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Average amounts of transfusion

  one week after surgery

Secondary Outcomes (2)

• Calculated blood loss

  one week after surgery

• thrombosis

  3 months after surgery

Study Arms (3)

Tranexamic acid, IA group

EXPERIMENTAL

Tranexamic acid 1g, intra-articular injection, post-operationally

Drug: Tranexamic acid

Tranexamic acid, IV group

ACTIVE COMPARATOR

Tranexamic acid, 1g, intravenous injection, post-operationally

Drug: Tranexamic acid

Tranexamic acid, IV+IA group

EXPERIMENTAL

Tranexamic acid, 1g, intravenous injection, post-operationally; Tranexamic acid, 1g, intra-articular injection, post-operationally

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

Tranexamic acid, IA group; Tranexamic acid, IV group; Tranexamic acid, IV+IA group

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 primary total knee arthroplasty on unilateral 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

• Xijing Hospital: lead

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

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: PRINCIPAL INVESTIGATOR
• PI Title: Doctor-in-charge

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 17, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

CN (1)