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Evaluation of Topical and Intravenous Tranexamic Acid in Surgical Treatment of Lumbar Degenerative Disease

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ClinicalTrials.gov Identifier: NCT02496364
Recruitment Status : Unknown
Verified May 2016 by Vinicius Magno da Rocha, Instituto Nacional de Traumatologia e Ortopedia.
Recruitment status was:  Enrolling by invitation
First Posted : July 14, 2015
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
Vinicius Magno da Rocha, Instituto Nacional de Traumatologia e Ortopedia

Brief Summary:
Lumbar degenerative disease surgery entails in a high blood loss, requiring often for blood transfusion. The cost and risks involved in the use of allogeneic blood have motivated research methods to reduce operative bleeding in these patients. One such method is the use of anti-fibrinolytic drugs, among which is tranexamic acid.

Condition or disease Intervention/treatment Phase
Other Fusion of Spine, Lumbar Region Scoliosis Drug: Placebo (Topical) Drug: Placebo (Intravenous) Drug: Tranexamic Acid (Topical) Drug: Tranexamic Acid (Intravenous) Phase 3

Detailed Description:
This study will enroll 144 middle-aged and aged patients undergoing Posterior Lumbar Interbody Fusion (PLIF) with the diagnosis of Lumbar Degenerative Disease. The primary aim is to determine if topical application of tranexamic acid is more effective than intravenous infusion at decreasing blood loss and blood transfusion perioperatively in middle-aged and aged patients presenting for PLIF surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical and Intravenous Use of Tranexamic Acid in Posterior Lumbar Interbody Fusion - A Prospective, Double-blind, Randomized Study
Study Start Date : March 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Active Comparator: Group A

Patients undergoing PLIF will be randomized for Intravenous and topical application of tranexamic acid.

  1. Tranexamic acid diluted in saline solution 0,9% to reach a concentration of 5mg/ml for Intravenous infusion;
  2. Tranexamic acid diluted in saline solution 0,9% to reach a concentration of 30mg/ml topical application.
Drug: Tranexamic Acid (Topical)
30mg/ml of tranexamic acid in situ during surgery, up to 100ml
Other Name: Transamin, TXA

Drug: Tranexamic Acid (Intravenous)
5mg/ml of tranexamic acid in the vein, up to 500ml: 200ml (5mg/ml) as loading dose over 15 minutes followed by 1ml/Kg/hr (5mg/ml) throughout the surgery, in a maximum volume of 300ml.
Other Name: Transamin, TXA

Placebo Comparator: Group B

Patients undergoing PLIF will be randomized for Intravenous infusion of tranexamic acid and topical application of placebo (i.e. saline solution 0,9%)

  1. Tranexamic acid diluted in saline solution 0,9% to reach a concentration of 5mg/ml for Intravenous infusion;
  2. Placebo for topical application, up to 100ml
Drug: Placebo (Topical)
Saline Solution 0,9% in situ, up to 100ml;
Other Name: Saline Solution 0,9%

Drug: Tranexamic Acid (Intravenous)
5mg/ml of tranexamic acid in the vein, up to 500ml: 200ml (5mg/ml) as loading dose over 15 minutes followed by 1ml/Kg/hr (5mg/ml) throughout the surgery, in a maximum volume of 300ml.
Other Name: Transamin, TXA

Placebo Comparator: Group C

Patients undergoing PLIF will be randomized for topical application of tranexamic acid and intravenous infusion of placebo (i.e. saline solution 0,9%)

  1. Tranexamic acid diluted in saline solution 0,9 to reach a concentration of 30mg/ml for topical application;
  2. Placebo for intravenous infusion, up to 500ml
Drug: Placebo (Intravenous)
Saline Solution 0,9% in the vein, up to 500ml: 200ml as loading dose over 15 minutes followed by 1ml/Kg/hr throughout the surgery, in a maximum volume of 300ml
Other Name: Saline Solution 0,9%

Drug: Tranexamic Acid (Topical)
30mg/ml of tranexamic acid in situ during surgery, up to 100ml
Other Name: Transamin, TXA

Placebo Comparator: Group D

Patients undergoing PLIF will be randomized for Intravenous and topical application of placebo (i.e. saline solution 0,9%).

  1. Placebo for intravenous infusion, up to 500ml;
  2. Placebo for topical application, up to 100ml.
Drug: Placebo (Topical)
Saline Solution 0,9% in situ, up to 100ml;
Other Name: Saline Solution 0,9%

Drug: Placebo (Intravenous)
Saline Solution 0,9% in the vein, up to 500ml: 200ml as loading dose over 15 minutes followed by 1ml/Kg/hr throughout the surgery, in a maximum volume of 300ml
Other Name: Saline Solution 0,9%




Primary Outcome Measures :
  1. Blood loss measurement [ Time Frame: 27 hours ]
    Intraoperative blood loss (3 hours) plus 24 hours postoperative blood loss will be measured in ml/kg


Secondary Outcome Measures :
  1. Blood transfusion necessity [ Time Frame: 27 hours ]
    Hemoglobin level less than 8g/dl, hematocrit less than 24% or others symptoms suggesting hypovolemia will be indicatives for blood transfusion intraoperative and postoperative.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of lumbar degenerative disease with segmental instability and/or lumbar stenosis;
  • Having a body weight less than 100kg
  • Indicative of Posterior lumbar interbody fusion in three levels or less

Exclusion Criteria:

  • Diagnosis of renal and hepatic insufficiency
  • History of bleeding disorders and thromboembolism
  • History coronary heart disease
  • History peripheral vascular disease
  • Commonly used anticoagulant drug
  • Contraindication to the use of tranexamic acid
  • Surgery history in the spine
  • Religious restrictions on blood transfusion

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): NCT02496364


Sponsors and Collaborators
Instituto Nacional de Traumatologia e Ortopedia
Investigators
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Principal Investigator: Vinicius M da Rocha, M.D. National Institute of Traumatology and Orthopedics
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Responsible Party: Vinicius Magno da Rocha, M.D., Instituto Nacional de Traumatologia e Ortopedia
ClinicalTrials.gov Identifier: NCT02496364    
Other Study ID Numbers: ATX-2015
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Vinicius Magno da Rocha, Instituto Nacional de Traumatologia e Ortopedia:
Tranexamic Acid
Scoliosis
bleeding control
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Tranexamic Acid
Pharmaceutical Solutions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants