NCT01391182

Brief Summary

You are being asked to take part in this research study because you are scheduled to have total hip replacement (arthroplasty) surgery. The goal of this study is to evaluate the effectiveness of the drug, epsilon Aminocaproic Acid (EACA), in decreasing the need for patients to receive blood after surgery. Currently, EACA is approved by the Federal Drug Administration (FDA) to treat a patient who is bleeding. The investigators plan to use EACA to prevent bleeding during and after surgery; use of this drug as a means of preventing bleeding is not currently approved by the FDA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 26, 2015

Status Verified

February 1, 2015

Enrollment Period

3.5 years

First QC Date

July 7, 2011

Last Update Submit

February 25, 2015

Conditions

Degenerative Joint DiseaseOsteoarthritis

Keywords

Epsilon Aminocaproic Acidblood losstotal hip arthroplastyreduction in blood transfusionsAmicar

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin levels and transfusion rates.

    Postoperative hemogloblins will be monitored on postop day 1, 2, and 3.

    96 hours after total hip arthroplasty surgery.

Study Arms (2)

EACA arm

ACTIVE COMPARATOR

In order to obtain sufficient power, a total of 120 patients will be studied, 60 in each group. The surgeon performing the case, their staff, the anesthesiologist, nurse anesthetist and the patient will be blinded to whether the patient received EACA or placebo. Pharmacy will prepare the EACA dose or the saline. Serum hemoglobin levels with be drawn preoperatively and on post operative days one, two, and three. The first dose will be given in the operating room prior to incision (within 30 minutes of the incision). The second dose will be given four hours after the first dose. Two doses are given due to the short half-life of EACA. The timing of administration of EACA will be recorded.

Other: EACA

Placebo arm

PLACEBO COMPARATOR

In order to obtain sufficient power, a total of 120 patients will be studied, 60 in each group. The surgeon performing the case, their staff, the anesthesiologist, nurse anesthetist and the patient will be blinded to whether the patient received EACA or placebo. Pharmacy will prepare the EACA dose or the saline. Serum hemoglobin levels with be drawn preoperatively and on post operative days one, two, and three. The first dose will be given in the operating room prior to incision (within 30 minutes of the incision). The second dose will be given four hours after the first dose. Two doses are given due to the short half-life of EACA. The timing of administration of EACA will be recorded.

Other: Placebo arm

Interventions

EACAOTHER

EACA 5 grams IV (mixed in NS) given in two doses: prior to incision (total hip arthroplasty) and repeated 4 hours later.

EACA arm
Placebo armOTHER

Placebo (NS) IV given in two doses: prior to incision (total hip arthroplasty) and repeated 4 hours later.

Placebo arm

Eligibility Criteria

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

You may qualify if:

  • Scheduled for a primary total hip arthroplasty to be performed at the Mayo Clinic
  • A preoperative hemoglobin between 10.0 and 13.5

You may not qualify if:

  • A preoperative hemoglobin less than 10.0 or greater than 13.5
  • Revision arthroplasty;
  • Arthroplasty performed for acute fracture
  • Inability to obtain informed consent;
  • Allergy to EACA
  • Pregnancy
  • History of coronary stenting \< 6 months
  • Heart valve replacement;
  • Renal disease,
  • Coagulopathy, DIC,
  • embolic stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Joint DiseasesOsteoarthritisHemorrhage

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesArthritisRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mary I O'Connor, MD

    Mayo Clinic Jacksonville, Chair, Orthopedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Orthopedic Surgery

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 11, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 26, 2015

Record last verified: 2015-02

Locations

US(1)