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Trial record 61 of 419 for:    TRANEXAMIC ACID

Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02829346
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
piya pinsornsak, Thammasat University

Brief Summary:
This study evaluates the peri-articular tranexamic acid injection in total knee arthroplasty which is an alternative route of administration for blood loss reduction. Half of participants will receive intravenous tranexamic acid injection, while the other half will receive peri-articular tranexamic acid injection during total knee arthroplasty.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Peri-articular tranexamic acid Drug: Intravenous tranexamic acid Phase 2

Detailed Description:
Intravenous tranexamic acid (IV TXA) is one of the most effective agents in use for reducing blood loss following total knee arthroplasty (TKA) but its safety regarding venous thromboembolic events (VTEs) remains in question. The direct, local application of TXA may reduce systemic toxicity whilst maintaining good or better bleeding control compared to IV TXA. The topical application of TXA via Hemovac drains has been reported previously with good results. However, there are no data on peri-articular TXA injections during TKA.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty: A Randomized Controlled Trial
Study Start Date : October 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Peri-articular group
Patients received 750 mg of peri-articular Tranexamic acid (Transamin®; OLIC Thailand Ltd, Bangkok, Thailand; 250 mg/5 mL, 15 cc total volume) injection into the soft tissue around medial capsule (5 ml), lateral capsule (5 ml) and around the quadriceps muscle (5 ml), 10 minutes prior to deflating the tourniquet and wound closure.
Drug: Peri-articular tranexamic acid
750 mg of peri-articular TXA, prior to deflating the tourniquet and wound closure
Other Name: Transamin

Active Comparator: Intravenous group
Patients received 750 mg of intravenous tranexamic acid(250 mg/5 ml, 15 cc total volume, keeping within the therapeutic range of 10-15 mg/kg/dose), 10 minutes prior to deflating the tourniquet and wound closure.
Drug: Intravenous tranexamic acid
750 mg of IV TXA, prior to deflating the tourniquet and wound closure
Other Name: Transamin




Primary Outcome Measures :
  1. The volume of postoperative blood loss in the drain [ Time Frame: 48 hours after the operation ]
  2. Changes from baseline hemoglobin concentrations [ Time Frame: 48 hours after the operation ]
  3. unit of blood transfusion [ Time Frame: 48 hours after the operation ]

Secondary Outcome Measures :
  1. Knee diameter for swelling [ Time Frame: At 24 and 48 hours after the operation ]
  2. number of patient with venous thromboembolism [ Time Frame: At 14 days after the operation ]


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Ages Eligible for Study:   Child, 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)
  • know allergy to TXA
  • defective color vision
  • preoperative hemoglobin <10 g/dL
  • platelet count < 140,000 /uL3

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): NCT02829346


Locations
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Thailand
Orthopaedic department, Thammasat university hospital
Klongluang, Pathumthani, Thailand, 12120
Sponsors and Collaborators
Thammasat University
Investigators
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Principal Investigator: Piya Pinsornsak, MD Faculty of Medicine, Thammasat university

Publications:
Aggarwal AK, Singh N, Sudesh P. Topical vs Intravenous Tranexamic Acid in Reducing Blood Loss After Bilateral Total Knee Arthroplasty: A Prospective Study. J Arthroplasty. 2015 Dec 21. pii: S0883-5403(15)01114-6. doi:10.1016/j.arth.2015.12.033. [Epub ahead of print]

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: piya pinsornsak, Dr., Thammasat University
ClinicalTrials.gov Identifier: NCT02829346     History of Changes
Other Study ID Numbers: MTU-EC-OT-0-096/54
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by piya pinsornsak, Thammasat University:
Tranexamic acid
Peri-articular injection
Total knee arthroplasty
Blood loss
Osteoarthritis, Knee
Additional relevant MeSH terms:
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Tranexamic Acid
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants