NCT04312880

Brief Summary

Tranexamic acid (TXA) is an agent that has been shown to be safe and effective to reduce blood loss in surgical procedures. The purpose of the study is to assess the effect of transexamic on elective decompressive lumbar spine surgery with and without fusion.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

December 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

2.1 years

First QC Date

March 9, 2020

Last Update Submit

August 10, 2020

Conditions

Spine Surgery

Outcome Measures

Primary Outcomes (1)

  • Drain output

    Drains will be placed during surgery, this will be recorded by nursing staff on a regular schedule and we will assess the results as a surrogate for blood loss post operatively

    48 hours postoperatively

Secondary Outcomes (6)

  • Change in hematocrit

    two days post operatively

  • Change in hemoglobin

    two days post operatively

  • Emergency department visits

    30 days post operatively

  • number of hospital readmissions

    30 days post operatively

  • Incidence of PE

    30 days post opertively

  • +1 more secondary outcomes

Study Arms (3)

Control

NO INTERVENTION

Patient will receive no transexemic acid of any kind

IV-transexemic acid

EXPERIMENTAL

weight adjusted standard dose of TXA will be administered to these subset of patients prior to incision in IV-form

Drug: Tranexamic Acid

Topical-transexemic acid

EXPERIMENTAL

the wound site after the surgery is completed will be bathed in TXA for a standardized period of time prior to skin closure

Drug: Tranexamic Acid

Interventions

Tranexamic AcidDRUG

IV and topical form of TXA will be administered to patients in the respective groups.

IV-transexemic acidTopical-transexemic acid

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing decompressive lumbar laminectomy with or without fusion
  • Primary surgical procedure
  • Competent adult able to give informed consent
  • Age \>18

You may not qualify if:

  • h/o DVT or PE
  • h/o seizure
  • h/o coagulopathy
  • Diagnosis of malignancy or infection as indication for surgical decompression
  • Abnormal pre-operative PT/INR, aPTT, bleeding time
  • Platelet count \< 100
  • Patients requiring therapeutic heparin or lovenox bridges prior to and/or after surgery
  • Allergy to TXA
  • Pregnant women and prisoners
  • Renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • James Lawrence, MD

    Attending Surgeon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 18, 2020

Study Start

December 1, 2018

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)