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Trial record 65 of 419 for:    TRANEXAMIC ACID

Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery

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ClinicalTrials.gov Identifier: NCT02063035
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Kirkham Wood, Massachusetts General Hospital

Brief Summary:

Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine surgery will decrease the overall blood loss post-operatively. This reduction in blood loss will reduce the need for transfusion. In addition it will also significantly reduce the cost of the surgical procedure.

Specific Aim 1: The goal of this study is to quantitatively assess whether topical application of tranexamic acid placed into the surgical wound during lumbar spine surgery will decrease post-operative blood loss, thus lowering the need for blood transfusions. By reducing the number of transfusions participants can avoid the well-known complications associated with them. The investigators do not plan on measuring serum tranexamic acid levels.

Several meta-analyses and level I studies have shown that intravenous (IV) administration of tranexamic acid is effective in reducing postoperative blood loss and the need for transfusion.


Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Thoracic Spinal Stenosis Drug: Tranexamic Acid Drug: Placebo Phase 4

Detailed Description:

Tranexamic acid, an antifibrinolytic agent, has been studied at great length across a myriad of medical specialties to reduce blood lost during these surgeries. Topical tranexamic acid administration reduces postoperative blood loss and proved safe in multiple types of surgeries -e.g. cardiothoracic, oral and maxillofacial, eye, ear and throat.(References: Fawzy and others [et al], Wong et al, Zufferey et al, Wang et al, Ipema et al).

Intravenous tranexamic acid administration has been shown to reduce postoperative blood loss and transfusion need in patients undergoing spinal surgery (Reference: Elwatidy et al). Some advocates have suggested that topical (i.e. local) administration might be preferred over intravenous application. Topical administration of tranexamic acid has some potential advantages as it leads to lower systemic absorption, and offers less concern over the risk of thromboembolic complications (References: Wong et al, Raveendran et al).

While systemic (intravenous) use of tranexamic acid has been studied in spine surgery, there has been little studied to show its effectiveness at reducing blood loss when used topically.

This study proposes to determine if the topical application of tranexamic acid into the surgical wound of posterior multi-level lumbar spine surgery will decrease postoperative blood loss, thus decreasing the need for potential transfusions. Tranexamic acid has been well documented for its safety and efficacy, the investigators believe that this agent will become an important tool to reduce the blood loss in spinal surgeries. It offers a reduction in blood loss and, ultimately, a decrease in the transfusion rates which pose risks to the subject and significant cost.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Topical Application of Tranexamic Acid to Reduce Postoperative Blood Loss in Posterior Approach Spinal Surgery
Actual Study Start Date : August 2012
Actual Primary Completion Date : April 22, 2015
Actual Study Completion Date : April 22, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic acid
Participants undergoing spinal surgery will receive a single, topical dose of tranexamic acid. The surgeon will irrigate the study medication in the wound prior to closure, and aspirate it after five minutes. Drains will be placed after the study drug has been aspirated.
Drug: Tranexamic Acid
A single topical application of 3 grams (g) of Tranexamic acid in 100 milliliter (mL) saline.
Other Name: Cyklokapron®

Placebo Comparator: Placebo
Participants undergoing spinal surgery will receive a single, topical dose of matching placebo. The surgeon will irrigate the study medication in the wound prior to closure, and aspirate it after five minutes. Drains will be placed after the study drug has been aspirated.
Drug: Placebo
A single topical application of matching placebo, which is 100 mL of normal saline.




Primary Outcome Measures :
  1. Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge [ Time Frame: From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery ]
    Blood loss was calculated from the difference between the level of hemoglobin at the preoperative appointment and the lowest level during the postoperative hospitalization period. Reported here is the change in hemoglobin level after surgery. A negative number indicates a reduction in hemoglobin level.


Secondary Outcome Measures :
  1. Blood Loss Volume Following Surgery [ Time Frame: From end of surgery on Day 1 to end of hospital stay up to approximately 5 days ]
    Blood loss following surgery was defined as the total amount of fluid collected from the drain in the wound site during the hospital stay.

  2. Hospital Length of Stay in Days [ Time Frame: From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeks ]
    The number of days the participants stayed in the hospital after surgery was recorded.

  3. Post-operative Blood Transfusions During Hospitalization [ Time Frame: From end of surgery on Day 1 to end of hospital stay up to approximately 5 days ]
    All units of blood transfused during the hospital stay after surgery were recorded. One red blood cell unit contains 300 to 360 mL of whole blood.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-85 years, both male and female
  • Undergoing elective multi-level spinal surgery with a posterior approach to the thoracolumbar spine.
  • Negative pregnancy test

Exclusion Criteria:

  • Allergy to tranexamic acid
  • Preoperative anemia (Hemoglobin <11 grams per deciliter [g/dL] )
  • Coagulopathy (preoperative platelet count <150,000, International Normalized Ratio >1.4, or Partial Thromboplastin Time > 1.5 times normal)
  • History of deep vein thrombosis, stroke, or pulmonary embolism
  • Pregnant or breast feeding
  • Liver function tests 2 times the upper limit of normal, and those with creatine greater than 1.6 milligrams per deciliter (mg/dL)
  • Infection
  • Revision procedure in which the only procedure is removing instrumentation
  • Renal impairment
  • Dural tear

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): NCT02063035


Locations
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United States, Massachusetts
Massachusetts General Hospital Orthopedic Spine
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Kirkham B Wood, MD Massachusetts General Hospital

Publications:

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Responsible Party: Kirkham Wood, Associate Professor at Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02063035     History of Changes
Other Study ID Numbers: 2012P000266
2012P000266 ( Other Identifier: Massachusetts General Hospital IRB approved )
First Posted: February 14, 2014    Key Record Dates
Results First Posted: June 8, 2017
Last Update Posted: June 8, 2017
Last Verified: June 2017
Keywords provided by Kirkham Wood, Massachusetts General Hospital:
lumbar spine surgery
thoracic spine surgery
Additional relevant MeSH terms:
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Tranexamic Acid
Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants