Trial · NCT04272606

TXA in Spinal Fusion

NCT04272606, Phase 2, Completed, Catherine R. Olinger; results first posted 2024-05-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. TXA in Spinal Fusion. Trials, record NCT04272606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04272606

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: TXA in Spinal Fusion
NCT number: NCT04272606
Status: Completed
Phases: Phase 2
Enrollment: 123 participants, actual
Lead sponsor: Catherine R. Olinger
Conditions: Degenerative Disc Disease
Interventions: Tranexamic Acid, Saline Solution, Visual Acuity Exam, 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
First posted: 2020-02-17
Last updated: 2024-12-12
Results first posted: 2024-05-14

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Transfusion	Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported	The number of participants who had red blood cells (RBC) transfused: 1. Intraoperatively 2. Postoperatively (prior to discharge or at day 5, whichever occurred first) 3. Either Intraoperatively or Postoperatively
Primary	Blood Loss	Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported	Amount of blood loss: 1. Intraoperatively 2. Postoperatively (prior to discharge or at day 5, whichever occurred first) 3. Either Intraoperatively or Postoperatively
Primary	Delirium Occurrence	Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported	Delirium occurrence (yes/no) using daily 3D-CAM delirium assessment instrument.
Secondary	Delirium Severity	Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported	Severity (score 0-20) using daily 3D-CAM delirium assessment instrument. Minimum=0 (no delirium) Maximum=20 (worse delirium)
Secondary	Change in Interleukin-6 Concentration.	Preoperatively and 24 hours postoperatively	Measure of systemic inflammation using Interleukin-6 change between preoperative and 24 postoperatively blood draw.
Secondary	Length of Postoperative Stay Prior to Discharge	Days thru day of discharge	Length of postoperative stay prior to discharge in days

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Transfusion	Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Blood Loss	Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported	ml per instrumented vertebral level	MEDIAN
PRIMARY	Delirium Occurrence	Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported	participants with delirium	NUMBER
SECONDARY	Delirium Severity	Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported	3D-CAM Points	MEDIAN
SECONDARY	Change in Interleukin-6 Concentration.	Preoperatively and 24 hours postoperatively	pg per ml	MEDIAN
SECONDARY	Length of Postoperative Stay Prior to Discharge	Days thru day of discharge	Days	MEDIAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Transfusion	Treatment	Intraoperatively	7		Participants
Transfusion	Placebo	Intraoperatively	6		Participants
Transfusion	Treatment	Postoperatively (prior to discharge or at day 5, whichever occurred first)	9		Participants
Transfusion	Placebo	Postoperatively (prior to discharge or at day 5, whichever occurred first)	8		Participants
Transfusion	Treatment	Either Intraoperatively or Postoperatively	10		Participants
Transfusion	Placebo	Either Intraoperatively or Postoperatively	10		Participants
Blood Loss	Treatment	Intraoperatively	167	Inter-Quartile Range 87 to 250	ml per instrumented vertebral level
Blood Loss	Placebo	Intraoperatively	110	Inter-Quartile Range 67 to 176	ml per instrumented vertebral level
Blood Loss	Treatment	Postoperatively (prior to discharge or at day 5, whichever occurred first)	128	Inter-Quartile Range 97 to 186	ml per instrumented vertebral level
Blood Loss	Placebo	Postoperatively (prior to discharge or at day 5, whichever occurred first)	207	Inter-Quartile Range 132 to 258	ml per instrumented vertebral level

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment	44
Overall Study	STARTED	Placebo	42
Overall Study	COMPLETED	Treatment	43
Overall Study	COMPLETED	Placebo	40
Overall Study	NOT COMPLETED	Treatment	1
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events10

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Vision Change	Eye disorders	Treatment	2	43	2
other	Vision Change	Eye disorders	Placebo	0	40	0
other	Renal Dysfunction	Renal and urinary disorders	Treatment	2	43	2
other	Renal Dysfunction	Renal and urinary disorders	Placebo	4	40	4
other	Wound Complication	Musculoskeletal and connective tissue disorders	Treatment	2	43	2
other	Wound Complication	Musculoskeletal and connective tissue disorders	Placebo	2	40	2
serious	Pulmonary Embolism	Blood and lymphatic system disorders	Treatment	0	43	0
serious	Pulmonary Embolism	Blood and lymphatic system disorders	Placebo	1	40	1
serious	Embolic stroke	Nervous system disorders	Treatment	0	43	0
serious	Embolic stroke	Nervous system disorders	Placebo	1	40	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment	0	43
Total, all-cause mortality	Placebo	0	40
Total, other adverse events	Treatment	6	43
Total, other adverse events	Placebo	6	40
Total, serious adverse events	Treatment	0	43
Total, serious adverse events	Placebo	2	40

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40276619	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Treatment vs Placebo: deaths from any cause	Trial comparisons
Treatment vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04272606

GET https://conductscience.org/api/trials/v1/NCT04272606/registered

API reference For AI assistants