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Trial record 23 of 34 for:    "Collagen Disease" | "Tranexamic Acid"

The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03074994
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
Krit Boontanapibul
Information provided by (Responsible Party):
piya pinsornsak, Thammasat University

Brief Summary:
Post-operative bleeding in total knee arthroplasty (TKA) can result in hypovolemic shock and unnecessity for allogenic blood transfusions. Intravenous and topical tranexamic acid (TXA) have been well established in reducing blood loss postoperatively. However, there are lack of data on peri-articular TXA injection during TKA. Therefore, the investigators conducted a three-arm prospective, randomized, controlled trial to compare the effectiveness of bleeding reduction of peri-articular TXA injections, intraarticular TXA injections and control group.

Condition or disease Intervention/treatment Phase
Osteoarthritis,Knee Drug: Peri-articular TXA (15 mg/kg) Drug: Intraarticular TXA 2 g (40 mL) Procedure: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area Procedure: TXA 40 mL inject into intraaricular knee capsule Phase 2

Detailed Description:
Patients scheduled for unilateral primary TKA; 108 patients were randomly assigned to receive peri-articular TXA, intraarticular TXA and control group. 36 patients received either: (I) 15 mg/kg peri-articular TXA combined with multimodal local anesthetic infiltration (bupivacaine, morphine, ketorolac and epinephrine) into the anterior soft tissue, medial gutter area, lateral gutter area prior to capsular closure and tourniquet deflation (group 1). (II) 2 g of intraarticular TXA after complete capsular closure just before tourniquet deflation (group 2). (III) Don't receive any route of TXA in control group (group 3). Hemoglobin (Hb) concentrations were measured at 24 and 48 hour, and the number of blood transfusions and knee circumference measurements were recorded. Serum TXA was recorded at 2 and 24 hours after operation. The reviewers were blinded to treatment group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty: A Prospective, Double-Blind Randomized, Controlled Trial
Study Start Date : October 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Peri-articular tranexamic acid injection
TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue+Medial gutter area+Lateral gutter area)
Drug: Peri-articular TXA (15 mg/kg)
combined with multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg) mixed NSS up to 75 mL

Procedure: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area
(Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation

Experimental: Intraarticular tranexamic acid injection
TXA inject into intraaricular knee capsule after multimodal local anesthetic infiltration
Drug: Intraarticular TXA 2 g (40 mL)
inject separate from multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 75 mL)

Procedure: TXA 40 mL inject into intraaricular knee capsule
after multimodal local anesthetic infiltration (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to tourniquet deflation

No Intervention: Control group
Don't receive any route of TXA



Primary Outcome Measures :
  1. Changes from baseline hemoglobin concentrations [ Time Frame: 48 hours after the operation ]
  2. Unit of blood transfusion [ Time Frame: 48 hours after the operation ]

Secondary Outcome Measures :
  1. Tranexamic acid level in blood [ Time Frame: 2 and 24 hours after the operation ]
  2. Knee diameter for swelling [ Time Frame: 24 and 48 hours after the operation ]
  3. Local soft tissue complications [ Time Frame: 14 days after the operation ]
  4. Skin necrosis [ Time Frame: 24 and 48 hours after the operation ]
  5. Number of patient with venous thromboembolism [ Time Frame: 14 days after the operation ]
  6. Visual Analogue Scales [ Time Frame: 24 and 48 hours after the operation ]
    (VAS, 0 = no pain, 10 = the worst imaginable pain)

  7. Knee flexion angle [ Time Frame: 24 and 48 hours after the operation ]


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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with osteoarthritis in need of a TKA

Exclusion Criteria:

  • Inflammatory arthritis
  • Post-traumatic arthritis
  • A history of or current venous thromboembolic disease
  • Any underlying disease of haemostasis, cirrhosis, chronic renal failure, patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel)
  • Preoperative hemoglobin <10 g/dL or a platelet count < 140,000 /uL3
  • Allergy to TXA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074994


Contacts
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Contact: Piya Pinsornsak, MD pinpiya2003@yahoo.com

Locations
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Thailand
Thammasat university hospital Recruiting
Pathumthani, Klongluang, Thailand, 12120
Contact: Piya Pinsornsak, MD    02-926-9705    pinpiya2003@yahoo.com   
Sponsors and Collaborators
Thammasat University
Krit Boontanapibul

Publications of Results:

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Responsible Party: piya pinsornsak, Principal Investigator, Thammasat University
ClinicalTrials.gov Identifier: NCT03074994     History of Changes
Other Study ID Numbers: MTU-EC-OT-6-063/59
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by piya pinsornsak, Thammasat University:
Tranexamic acid
Peri-articular injection
Intraarticular injection
Total knee arthroplasty
Blood loss

Additional relevant MeSH terms:
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Rheumatic Diseases
Tranexamic Acid
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants