NCT02063035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2015

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

June 8, 2017

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

2.7 years

First QC Date

December 19, 2013

Results QC Date

March 23, 2017

Last Update Submit

June 6, 2017

Conditions

Lumbar Spinal StenosisThoracic Spinal Stenosis

Keywords

lumbar spine surgerythoracic spine surgery

Outcome Measures

Primary Outcomes (1)

  • Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge

    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.

    From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery

Secondary Outcomes (3)

  • Blood Loss Volume Following Surgery

    From end of surgery on Day 1 to end of hospital stay up to approximately 5 days

  • Hospital Length of Stay in Days

    From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeks

  • Post-operative Blood Transfusions During Hospitalization

    From end of surgery on Day 1 to end of hospital stay up to approximately 5 days

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Tranexamic AcidDRUG

A single topical application of 3 grams (g) of Tranexamic acid in 100 milliliter (mL) saline.

Also known as: Cyklokapron®
Tranexamic acid
PlaceboDRUG

A single topical application of matching placebo, which is 100 mL of normal saline.

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital Orthopedic Spine

Boston, Massachusetts, 02114, United States

Location

Related Publications (10)

  • Fawzy H, Elmistekawy E, Bonneau D, Latter D, Errett L. Can local application of Tranexamic acid reduce post-coronary bypass surgery blood loss? A randomized controlled trial. J Cardiothorac Surg. 2009 Jun 18;4:25. doi: 10.1186/1749-8090-4-25.

    PMID: 19538741BACKGROUND

  • Gill JB, Chin Y, Levin A, Feng D. The use of antifibrinolytic agents in spine surgery. A meta-analysis. J Bone Joint Surg Am. 2008 Nov;90(11):2399-407. doi: 10.2106/JBJS.G.01179.

    PMID: 18978408BACKGROUND

  • Thompson GH, Florentino-Pineda I, Poe-Kochert C. The role of amicar in decreasing perioperative blood loss in idiopathic scoliosis. Spine (Phila Pa 1976). 2005 Sep 1;30(17 Suppl):S94-9. doi: 10.1097/01.brs.0000175188.05542.a9.

    PMID: 16138073BACKGROUND

  • Hynes MC, Calder P, Rosenfeld P, Scott G. The use of tranexamic acid to reduce blood loss during total hip arthroplasty: an observational study. Ann R Coll Surg Engl. 2005 Mar;87(2):99-101. doi: 10.1308/147870805X28118.

    PMID: 15826417BACKGROUND

  • Elwatidy S, Jamjoom Z, Elgamal E, Zakaria A, Turkistani A, El-Dawlatly A. Efficacy and safety of prophylactic large dose of tranexamic acid in spine surgery: a prospective, randomized, double-blind, placebo-controlled study. Spine (Phila Pa 1976). 2008 Nov 15;33(24):2577-80. doi: 10.1097/BRS.0b013e318188b9c5.

    PMID: 19011538BACKGROUND

  • Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.

    PMID: 21048170BACKGROUND

  • Raveendran R, Wong J. Tranexamic acid reduces blood transfusion in surgical patients while its effects on thromboembolic events and mortality are uncertain. Evid Based Med. 2013 Apr;18(2):65-6. doi: 10.1136/eb-2012-100872. Epub 2012 Aug 4. No abstract available.

    PMID: 22864370BACKGROUND

  • Zufferey P, Merquiol F, Laporte S, Decousus H, Mismetti P, Auboyer C, Samama CM, Molliex S. Do antifibrinolytics reduce allogeneic blood transfusion in orthopedic surgery? Anesthesiology. 2006 Nov;105(5):1034-46. doi: 10.1097/00000542-200611000-00026.

    PMID: 17065899BACKGROUND

  • Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23.

    PMID: 25450009BACKGROUND

  • Ipema HJ, Tanzi MG. Use of topical tranexamic acid or aminocaproic acid to prevent bleeding after major surgical procedures. Ann Pharmacother. 2012 Jan;46(1):97-107. doi: 10.1345/aph.1Q383. Epub 2011 Dec 27.

    PMID: 22202494BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Dr. Kirkham B. Wood
Organization
Massachusetts General Hospital, Boston, MA, USA
kbwood@stanford.edu
617-726-2000

Study Officials

  • Kirkham B Wood, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor at Harvard Medical School

Study Record Dates

First Submitted

December 19, 2013

First Posted

February 14, 2014

Study Start

August 1, 2012

Primary Completion

April 22, 2015

Study Completion

April 22, 2015

Last Updated

June 8, 2017

Results First Posted

June 8, 2017

Record last verified: 2017-06

Locations

US(1)