NCT03037515

Brief Summary

The purpose of this project is to compare the effectiveness of two different but well accepted routes of administration of tranexamic acid in order to reduce blood loss and need for transfusion in patients undergoing lumbar spine surgery. Specifically, this study seeks to identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2017

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

First Submitted

Initial submission to the registry

January 23, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

February 15, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2018

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

January 23, 2017

Last Update Submit

February 15, 2024

Conditions

Blood Loss, SurgicalBlood Loss Anemia

Outcome Measures

Primary Outcomes (1)

  • Intra-operative blood loss between the two groups

    For males: BV = 0.3669\*(Height in meters)\^3 + 0.03219\*(Weight in kilograms) + 0.6041 For females: BV = 0.3561\*(Height in meters)\^3 + 0.03308\*(Weight in kilograms) + 0.1833 Hbloss = BV\*(Hbi-Hbe )\*0.001 + Hbt Blood loss = 1000\*(Hbloss/Hbi) Hbloss = Hemoglobin loss; BV = Blood Volume; Hbi = initial Hgb; Hbe = ending Hgb; Hbt = transfused Hgb = about 52g (SD 5.4g) per 1u pRBC (320mL)

    Day of surgery to 1 day after surgery, up to 7 days

Secondary Outcomes (5)

  • Post-operative drop in hemoglobin between the two groups

    1 day after surgery until patient is discharged, up to 7 days

  • Post-operative blood loss between the two groups

    1 day after surgery until patient is discharged, up to 7 days

  • Number of units transfused between the two groups

    1 day after surgery until patient is discharged, up to 7 days

  • Post-operative drain output between the two groups

    1 day after surgery until patient is discharged, up to 7 days

  • Incidence of thromboembolic events between the two groups

    1 day after surgery until patient returns for first postoperative visit (through study completion, an average of 4 weeks after surgery)

Study Arms (2)

Intravenous Tranexamic Acid

ACTIVE COMPARATOR

The IV TXA group will receive the standard dosing for our institution of 1 g TXA (diluted in 100 mL normal saline) given as an IV bolus immediately before incision and another 1 g TXA given before closure.

Drug: Tranexamic Acid

Oral Tranexamic Acid

ACTIVE COMPARATOR

The oral TXA group will receive 1950 mg TXA (3 tablets of 650 mg) approximately 2 hours before incision.

Drug: Tranexamic Acid

Interventions

Tranexamic AcidDRUG

To identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion in lumbar spine surgery.

Also known as: Lysteda
Intravenous Tranexamic AcidOral Tranexamic Acid

Eligibility Criteria

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

You may qualify if:

  • Adult patients over age 18 and scheduled for open lumbar spine surgery (primary or revision)
  • Must be able to swallow tablets

You may not qualify if:

  • Known allergy to TXA
  • History of renal failure or kidney transplant
  • History of arterial thromboembolic event (eg. myocardial infarction, stroke) within the past year
  • Placement of an arterial stent within the past year
  • History of blood clots (DVT, PE) within the past year
  • Refusal to receive blood products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (2)

  • Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.

    PMID: 21936146BACKGROUND

  • Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111.

    PMID: 12697586BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Spine Surgeon

Study Record Dates

First Submitted

January 23, 2017

First Posted

January 31, 2017

Study Start

February 15, 2017

Primary Completion

June 15, 2018

Study Completion

July 16, 2018

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

US(1)