NCT05437822

Brief Summary

The purpose of this study is to determine the effect of tranexamic acid (on blood loss and transfusion requirements in patients with proximal humeral fractures requiring open surgical approaches. This a blinded, controlled, therapeutic trial in which the patients will be randomized to receive TXA or no drug intervention. The primary outcome is the estimated total blood loss. This study presents only minimal risks for the included patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

June 18, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 29, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2023

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

12 months

First QC Date

June 18, 2022

Last Update Submit

June 29, 2022

Conditions

Proximal Humeral FractureSurgical Treatment

Keywords

proximal humeral fracturesurgical treatmentTranexamic acid

Outcome Measures

Primary Outcomes (1)

  • Perioperative blood loss

    Measurement of loss (in mL), calculated with mathematical formulas proposed by Nadler and Good

    Hospital stay, from admission to third postoperative day.

Secondary Outcomes (3)

  • Blood transfusion rate

    Hospital stay, from admission to third postoperative day

  • Infection rate

    90 postoperative days

  • Thrombotic event rate

    90 postoperative days.

Study Arms (2)

TXA group

EXPERIMENTAL

Tranexamic acid, a topic dose of 2 g diluted in 50 mL saline solution infused in shoulder joint

Drug: Tranexamic acid

Control group

NO INTERVENTION

In the control group will not be administered TXA or any other drugs.

Interventions

Tranexamic acidDRUG

2 g of tranexamic acid in 50 mL of saline

TXA group

Eligibility Criteria

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

You may qualify if:

  • Acute proximal humeral fracture
  • Age over 18 years

You may not qualify if:

  • ASA IV
  • Concomitant fracture
  • Refusal to receive blood products
  • Allergy for tranexamic acid
  • Severe hepatic dysfunction (AST/ALT \>60)
  • Renal function impairment (serum creatinine \> 2 mg/dL or creatinine clearance \<30 mL/min),) or kidney transplant
  • Active acute thromboembolic event in the past 12 months (Deep Vein Thrombosis, Pulmonary)
  • Active coronary artery disease or cerebrovascular accident (event in the past 12 months).
  • Coronary stents
  • History of hypercoagulability
  • Coagulopathy (INR \> 1.4)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elda University Hospital

Elda, Alicante, 03600, Spain

RECRUITING

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Alejandro Lizaur Utrilla, MD

    Orthopaedic Surgery Department, Elda University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro Lizaur-Utrilla, MD

CONTACT

+34 966989019lizaur1@telefonica.net

Emilio Sebastia-Forcada, MD

CONTACT

+34 966989019lizaur1@telefonica.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Patients will be allocated into two groups based on randomized 20-block method by an independent assistant using computer generated randomization
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: All patients will be treated surgically with an internal fixation or arthroplasty. The two patient groups will include: 1) Study group treated with topic tranexamic acid infused in shoulder joint; 2) Control group with no drug treatment. Blood transfusion criteria will remain consistent with hospital standards. Deep vein thrombosis (DVT) prophylaxis will remain consistent with hospital standards (subcutaneous heparin from admission until 12 hours prior to surgery and beginning 6 hours after surgery). Patients will be followed 30 days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Orthopaedic Surgery Department

Study Record Dates

First Submitted

June 18, 2022

First Posted

June 29, 2022

Study Start

June 29, 2022

Primary Completion

June 21, 2023

Study Completion

June 24, 2023

Last Updated

July 5, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)