Tranexamic Acid in Hip Fracture Surgery | NCT02736383

Studies
Tranexamic Acid in Hip Fracture Surgery

NCT02736383

Sponsor

Corewell Health West

Status

Completed

Last Update Posted

Sep 22, 2023Actual

Enrollment

142Actual

Phase

Not provided

Conditions

Hip Fracture

Interventions

Not provided

Countries

Not provided

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

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Mar 29, 2016

First Submission Date that Met QC Criteria

Apr 7, 2016

First Posted Date

Apr 13, 2016Estimated

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

Sep 21, 2023

Last Update Posted Date

Sep 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To determine if TXA utilization is effective at reducing transfusion rates in elderly patients undergoing surgery for treatment of a hip fractures.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

142Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tranexamic Acid		Patients that receive 2 gm TXA during surgery
No Tranexamic Acid		Patients that receive no TXA during surgery

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Transfusion Rate	Blood transfusion rates during the patients hospital stay will be assessed.	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Hospital Length of stay	The patients length of stay in the hospital will be determined.	6 weeks
Post operative complications	Post operative complications will be assessed through the 6 weeks.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute, isolated, unilateral femoral neck, intertrochanteric, and per trochanteric hip fractures confirmed by anteroposterior/lateral hip radiographs, computed tomography, or magnetic resonance imaging.
Age 65 and older
Low energy mechanism of injury
Hip fracture fixation performed within 48 hours
English speaking
Anticipated medical optimization for operative fixation
No other major trauma

Exclusion Criteria:

Retained hardware around the affected hip
Infection around the affected hip
Transfer patients with a length of stay > 24 hours at the transferring hospital
Diagnosis of deficient natural anticoagulation
Known congenital thrombophilia (Deficiency of Protein C, S, Antithrombin)
Known allergy to TXA
Patients undergoing percutaneous pinning of the hip fracture

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients with hip fractures

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Blake W Miller, DO	Corewell Health West	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

Not provided

Browse Branches

Not provided