Effect of Early Administration of TXA in Adult Hip Fractures

Postoperative Blood Loss Clinical Trial

Official title:

Does Early Administration of Tranexamic Acid Decrease Perioperative Blood Loss in Addition to Intraoperative Tranexamic Acid for Hip Fracture Patients?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05047133
• Other study ID #: 1722787-1
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2021
• Source: Ascension Genesys Hospital
• Contact: Jacob Hinkley, DO, MS
• Phone: 810-606-5669
• Email: jacob.hinkley2[@]ascension.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective clinical study designed to assess blood loss in intracapsular and extracapsular hip fractures undergoing operative fixation at a Level II trauma center. It is well established in the orthopedic literature that tranexamic acid (TXA) decreases blood loss and need for postoperative blood transfusion in hip fracture patients as well as total joint arthroplasty patients. A typical dosing pattern, and the dosing pattern employed at our institution, is 1 gram IV infused prior to incision followed by 1 gram IV infused at the time of wound closure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. All adult (18 years old or older) hip fracture patients presenting with an acute hip fracture and undergoing operative fixation

Exclusion Criteria:

1. Polytrauma patients

2. Previous operation on the ipsilateral hip

3. Patients with coagulopathies (Factor V Leiden, Sickle Cell Anemia, Etc.)

4. Patients with < 6-month history of thromboembolic event (DVT/PE), Stroke, Cardiac Stents, or Myocardial Infarction (MI)

5. History of seizure disorder

6. Patients on birth control

7. Pregnant Women

8. Prisoners

9. Active thromboembolic disease (DVT/PE, MI, Stroke)

Related Conditions & MeSH terms

• Hemorrhage
• Hip Fractures
• Postoperative Blood Loss
• Postoperative Hemorrhage

Intervention

Drug:
• Tranexamic acid
TXA to be given at time of diagnosis in the emergency department (ED) in treatment group and at time of operation for both groups

Locations

Country	Name	City	State
United States	Ascension Genesys Hospital	Grand Blanc	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ascension Genesys Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Blood Transfusion	Patient receives a blood transfusion during their postoperative stay in the hospital	Up to two weeks
Primary	Overall Blood Loss	Calculate the difference in postoperative blood loss between groups	Up to two weeks
Secondary	Length of hospital stay	Overall length of hospital stay	Up to two weeks
Secondary	Postoperative Pain	Difference in overall pain scores between groups	Up to two weeks
Secondary	Wound complications	Acute wound complications documented after surgical intervention	Up to two weeks
Secondary	Acute DVT/PE	Documented deep venous thrombosis or pulmonary embolism	Up to two weeks