The Effects of Tranexamic Acid on Blood Loss During Ortho... | NCT03433144

Studies
The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery

NCT03433144

Sponsor

Nick Emanuele

Status

Withdrawn

Last Update Posted

Aug 6, 2021Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Tranexamic Acid
Orthognathic Surgery

Interventions

Tranexamic Acid Injectable Solution
Placebo (normal saline 0.9%)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funding

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Feb 1, 2019Actual

Completion Date

Jul 6, 2020Actual

First Submitted Date

Feb 8, 2018

First Submission Date that Met QC Criteria

Feb 13, 2018

First Posted Date

Feb 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2021

Last Update Posted Date

Aug 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study seeks to answer the question: Does a single pre-operative dose of tranexamic acid have a statistically significant reduction in blood loss during orthognathic surgery?

If it does, this drug may begin to be used routinely during orthognathic surgery to reduce blood loss in our patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention TXA	Experimental	patients receiving TXA10mg/kg IV pre-operatively	Drug: Tranexamic Acid Injectable Solution
Placebo	Placebo Comparator	patients will receive an equivalent amount of normal saline 0.9% IV pre-operatively	Other: Placebo (normal saline 0.9%)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tranexamic Acid Injectable Solution	Drug	the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia	Intervention TXA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blood loss during surgery	meticulous measurement of the total blood loss encountered during surgery	intra-operative only

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing either
- Bilateral saggital split osteotomy (lower jaw surgery)
- Lefort 1 osteotomy (upper jaw surgery)
- Combination of BSSO and Lefort
Patients between with ages of 16-65
No cardiac comorbidities (hypertension, congenital heart malformation)
No known coagulopathy
No regular prescription medication altering normal blood coagulation (NSAIDs, other anticoagulants)
ASA I and II patients

Exclusion Criteria:

Patients younger than 16 and older than 40
Patients with known coagulopathy
Patients with cardiac comorbidities
Patients with a family history of bleeding disorders
Patients who have undergone previous orthognathic surgery
ASA III patients or higher

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nick Emanuele, DDS, BBA	Nova Scotia Health Authority	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nova Scotia Health Authority		Halifax	Nova Scotia	B4A 3W5	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

The data will be used for internal use only

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Model Description

In this study, patients will be randomized into two groups: and intervention group and placebo. The intervention group will receive a single pre-operative dose of TXA IV (10mg/kg) and the placebo group will receive the same volume of fluid intravenously.