Safety and Efficacy of Oral TXA in Reducing Blood Loss and Transfusion in Hip Fractures

NCT02908516 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2000020122
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the safety and efficacy of Tranexamic acid (TXA) in reducing blood loss and transfusion requirements for patients with osteoporotic hip fractures. In addition to assessing blood loss in these patients, complications associated with TXA use would be characterized including systemic (pulmonary embolism, deep venous thrombosis, myocardial infarction, stroke) and surgical site (hematoma, infection) events, need for re-hospitalization or re-operation and 30 day mortality.

Conditions

Hip Fractures; Blood Loss

Outcome Measures

Primary Outcomes (3)

• Total Blood Loss

  Postoperative day 3

• Change in Hemoglobin Level

  From presentation until postoperative day 3

• Number of Transfusion Events

  Postoperative day 3

Secondary Outcomes (2)

• Hospital Length of Stay

  During hospitalization, likely less than 1 week

• Complications

  6 weeks

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

Study subjects randomized to receive the TXA group will receive 3 oral capsules of 650 mg each of TXA for a total of 1.95 g. One dose will be given upon diagnosis of a hip fracture in the emergency department (ED) and a second dose will be given two hours prior to surgical incision.

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

Study subjects randomized to the placebo group will receive an equivalent dose of cellulose in 3 oral capsules. One dose will be given upon diagnosis of a hip fracture in the ED and a second dose will be given two hours prior to surgical incision.

Drug: Placebo

Interventions

Tranexamic Acid DRUG

2 doses of 1.95 g TXA orally, once in the ED and another dose pre-operatively.

Tranexamic acid

Placebo DRUG

2 doses of 1.95 g cellulose orally, once in the ED and another dose pre-operatively.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with femoral neck, intertrochanteric and subtrochanteric femur fractures Patients age 18 and older Low energy injury

You may not qualify if:

• Pregnant or breast-feeding women Allergy to tranexamic acid Acquired disturbances of color vision Thrombophilia Antithrombin deficiency Factor V Leiden Antiphospholipid Syndrome Protein C and S deficiency History of heparin induced thrombocytopenia Sickle cell anemia Myeloproliferative disorders International Normalized Ratio (INR) \> 1.4 Partial Thromboplastin Time (PTT) \> 1.4 times normal A history of arterial or venous thromboembolism Cerebral Vascular Accident Deep Vein Thrombosis Pulmonary Embolism Subarachnoid hemorrhage Active intravascular clotting Participation in another clinical trial

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06515, United States

Location

MeSH Terms

Conditions

Hip Fractures; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Michael P. Leslie
• Organization: Yale School of Medicine, Department of Orthopaedics and Rehabilitation

michael.leslie@yale.edu

(203) 737-6358

Study Officials

• Michael P Leslie, DO

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: September 21, 2016
• Study Start: September 18, 2017
• Primary Completion: November 14, 2017
• Study Completion: December 15, 2017
• Last Updated: July 29, 2019
• Results First Posted: July 29, 2019

Record last verified: 2019-07

Locations

US (1)