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TRANEXTKA: Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty

Sponsor
Irmandade da Santa Casa de Misericordia de Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT02323373
Collaborator
(none)
90
Enrollment
3
Arms
5
Duration (Months)

Study Details

Study Description

Brief Summary

This clinical trial investigated two different routes of administration of tranexamic acid in total knee arthroplasty: topical compared to intravenous.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic Acid - topical
  • Drug: Placebo
  • Drug: Tranexamic Acid - intravenous
 Phase 2

Detailed Description

Intravenous administration of tranexamic acid (TA) is common in orthopedic surgery. The ideal dose and administration route of the drug in total knee arthroplasty (TKA) is under investigation.

The objective of this randomized clinical trial was to verify differences between topical and intravenous administration of TA in TKA regarding blood loss and coagulation variables.

Patients undergoing TKA were randomized to receive TA intravenously (20 mg in 100 ml of saline), topically (1.5 g in 50 ml of saline, sprayed over the operated site, before closure) or intravenous saline (100 ml). Suction drains were maintained for 48 hours, in order to measure blood loss. Data analysis is being undertaken now, in order to compare the two routes of administration of the drug.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty: a Randomized Clinical Trial With 90 Patients
Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Topical group

Intervention: Tranexamic Acid - topical. Topical administration of a solution of 1.5 g of tranexamic acid (50 mg/ml, Transamin, Zydus Nikkho) diluted in 50 ml of saline (at 0.9%), sprayed over the operated area, covering it for 5 minutes, before the tourniquet release.

Drug: Tranexamic Acid - topical
Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this study arm, the drug is administered topically on the wound.
Other Names:
  • trans-4-(aminomethyl)cyclohexanecarboxylic acid

    		•
    Active Comparator: Intravenous group

    Intervention: Tranexamic Acid - intravenous Intravenous injection of 20 mg/kg of tranexamic acid, diluted in 100 ml of saline at 0.9%, administered with anesthesia in 10 minutes.

    Drug: Tranexamic Acid - intravenous
    Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this arm, the drug is administered intravenously.
    Other Names:
  • trans-4-(aminomethyl)cyclohexanecarboxylic acid

    		•
    Placebo Comparator: Placebo

    Intervention: intravenous injection of 100 ml of saline solution also administered with anesthesia in 10 minutes.

    Drug: Placebo
    100 ml of saline solution administered with anesthesia during 10 minutes
    Other Names:
  • Saline solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Blood loss [up to 48 hours from the end of surgery, with drained volume registered every 6 hours.]

      Volume of blood loss in the suction drain device after TKA surgery

    Secondary Outcome Measures

    1. Thrombosis [up to 15 days after surgery]

      Patients with events of thrombosis after TKA

    2. Need for transfusion [during or after surgery, during hospital stay (hospital discharge took place in four days, in average)]

      Number (or percentage) of patients requiring transfusion in TKA surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: Patients in need of unilateral total knee arthroplasty (TKA) due to arthrosis, Albach grades III and IV were eligible

    Exclusion Criteria:

    • history or identified risk for deep vein thrombosis or pulmonary embolism

    • history of coagulation or cardiovascular disorders

    • vascular diseases

    • pregnancy

    • current use of anticoagulation drugs

    • previous orthopedic surgery in the legs.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Irmandade da Santa Casa de Misericordia de Sao Paulo

    Investigators

    • Principal Investigator: Zekcer Ari, MD, PhD, Santa Casa de São Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ari Zekcer, MD, PhD, Irmandade da Santa Casa de Misericordia de Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT02323373
    Other Study ID Numbers:
    • ISCMSP
    First Posted:
    Dec 23, 2014
    Last Update Posted:
    Jan 14, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Ari Zekcer, MD, PhD, Irmandade da Santa Casa de Misericordia de Sao Paulo
    Arthroplasty, Replacement, Knee
    Tranexamic Acid
    Drug Administration Routes
    Additional relevant MeSH terms:
    Osteoarthritis
    Tranexamic Acid

    Study Results

    No Results Posted as of Jan 14, 2015