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Trial record 6 of 1775 for:    "Mayo Clinic" [Exact]

Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Brandon J Yuan, Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Brandon J Yuan, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03182751
First received: June 7, 2017
Last updated: NA
Last verified: June 2017
History: No changes posted
  Purpose
A single-center, prospective randomized study. Consecutive patients presenting with intertrochanteric hip fractures will be treated with tranexamic acid. Treatment will be initiated in the emergency department according to a previously studied protocol for trauma patients.

Condition Intervention Phase
Hip Fractures Drug: Tranexamic Acid (TXA) Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects will be randomized into one of two study groups: TXA administration (treatment) or placebo (control). In order to ensure balance on the subject demographics between the two study groups, the subjects will be stratified on gender, age group (<75 vs. ≥75) and body mass index (<30 vs. ≥30). Within each stratum, subjects will be assigned to either the treatment group or control group using an electronic dynamic allocation program housed in a computer application developed by personnel in the Division of Biomedical Statistics and Informatics.
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Masking Description:
Using dynamic allocation will ensure that the study subjects will remain balanced on the stratification factors and the treatment group assignment throughout the entire subject accrual phase. This system will be utilized by Central pharmacy personnel to generate the treatment group assignments. Medications will then be delivered from the Central Pharmacy to the emergency department in packaging that does not delineate whether it contains placebo or tranexamic acid. Thus, the patient, treating surgeon, emergency department physician, residents, hospitalist group, anesthesiologist, and data collectors will remain blinded to the treatment assignment.
Primary Purpose: Treatment
Official Title: Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement in Low Energy Hip Fracture Patients?

Resource links provided by NLM:


Further study details as provided by Brandon J Yuan, Mayo Clinic:

Primary Outcome Measures:
  • Proportion of patients transfused at least 1 unit of packed red blood cells [ Time Frame: Length of hospitalization; average stay is 3 to 5 days. ]
    Transfusion will be considered for all patients with hemoglobin values of less than 8 g/dL with persistent symptoms or history of significant cardiac disease that may render the patient less able to compensate for significant anemia. Blood transfusion will be considered in all patients with hemoglobin less than 7 g/dL, regardless of symptoms.


Secondary Outcome Measures:
  • Mean number of units transfused per patient [ Time Frame: Length of hospitalization; average stay is 3 to 5 days. ]
    Number of units of packed red blood cells per patient

  • Calculated blood loss [ Time Frame: Length of hospitalization; average stay is 3 to 5 days ]
    Calculated blood loss per patient

  • Incidence of symptomatic Venous Thromboembolism (VTE) [ Time Frame: Within 6 months of surgery ]
    Patients diagnosed with Venous Thromboembolism

  • Wound complications [ Time Frame: Within 6 months of surgery ]
    Any patient diagnosed with a wound complication

  • (Myocardial Infarction) MI diagnosed [ Time Frame: Within 6 months of surgery ]
    Any patient diagnosed with a myocardial infarction

  • Cerebrovascular accident (CVA) diagnosed [ Time Frame: Within 6 months of surgery ]
    Any patient diagnosed with a cerebrovascular accident

  • All-cause mortality [ Time Frame: At 6 months after surgery ]
    Any patient who suffers mortality


Estimated Enrollment: 156
Anticipated Study Start Date: June 25, 2017
Estimated Study Completion Date: June 25, 2019
Estimated Primary Completion Date: June 25, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tranexamic Acid Arm (TXA)
TXA will be administered intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours.
Drug: Tranexamic Acid (TXA)
The cohort of patients treated with early administration of TXA in the Emergency Department will be compared to a control group who were not treated with TXA at any point.
Other Name: Cyklokapron
Placebo Comparator: Control Arm
Patients in the control group will receive a placebo medication in the Emergency Department. Neither group will receive perioperative bolus dosing of TXA.
Drug: Placebo
The cohort of patients treated with a placebo in the Emergency Department will be compared to the active comparator group that will receive early administration of Tranexamic Acid.

Detailed Description:
The use of TXA in orthopedic trauma patients is an area of current research interest. A 2010 prospective randomized, controlled trial of perioperative TXA demonstrated reduction in transfusion requirements for intertrochanteric hip fractures treated with short, cephalomedullary nails. This was clinically, though not statistically, significant. Investigators recently conducted a randomized, controlled trial at this institution to evaluated the use of TXA in patients with femoral neck fractures treated with hemiarthroplasty or total hip arthroplasty and found clinically, albeit not statistically, significant reduction in transfusion requirement (accepted for publication). Perhaps tempering the effect seen with perioperative administration of TXA is the blood loss that occurs prior to surgery, the so-called "hidden" blood loss that can be as substantial as 1/3 of total blood loss from a hip fracture. This raises the question whether administration of tranexamic acid at the time of initial presentation after fracture could improve the perioperative care of these patients by decreasing the proportion of patients requiring transfusion and decreasing total blood loss.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • AO/OTA fracture classification 31A
  • Surgically treated with sliding hip screw or cephalomedullary nail (short or long)
  • Low energy, isolated injury
  • Age greater than 18 years old

Exclusion Criteria:

  • Intracapsular hip fractures: AO/OTA fracture classification 31B-C
  • Polytrauma patients
  • Creatinine clearance less than 30 mL/min
  • History of unprovoked VTE and/or recurrent VTE
  • Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
  • Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)
  • History of CVA, MI, or VTE within the previous 30 days
  • Coronary stent placement within the previous 6 months
  • Disseminated intravascular coagulation
  • Intracranial hemorrhage
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03182751

Contacts
Contact: Chelsea Boe, MD (507) 284-1175 boe.chelsea@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Chelsea Boe, MD    507-284-1175    boe.chelsea@mayo.edu   
Principal Investigator: Brandon Yuan, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Yuan Brandon, MD Mayo Clinic
  More Information

Responsible Party: Brandon J Yuan, Assistant Professor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03182751     History of Changes
Other Study ID Numbers: 16-004988
Study First Received: June 7, 2017
Last Updated: June 7, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: All patients will be monitored for signs and symptoms of reaction to the administration of tranexamic acid during administration and throughout their hospital stay. Their care will otherwise be performed in standard fashion, coordinated between the orthopedic trauma service and the hospitalist medicine team. A Data and Safety Monitoring Board (DSMB) comprised of two primary investigators (Dr. Brandon Yuan, Dr. Chelsea Boe), the study coordinator, and one outside faculty member (Dr. Kevin Perry) will meet quarterly. Outcome data including adverse events (VTE, MI, CVA, mortality, wound complications) will be compiled quarterly and reviewed by the DSMB. If there is concern for increased complication rates, the data will be submitted to the Department of Biostatistics for evaluation and comparison to a previously studied control group. In the event of increased adverse events in the treatment group, data would be submitted to the appropriate governing body for review.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on June 23, 2017