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Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery

NCT00320619 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2016-07-29

No results posted yet for this study

Summary

Individuals who undergo spine surgery often have a significant loss of blood and may require multiple blood transfusions. Research has shown that epsilon-aminocaproic acid (EACA) may reduce the amount of blood lost during surgery, which would decrease the number of blood transfusions required. This study will evaluate the safety and effectiveness of EACA at reducing blood loss and the need for blood transfusions in individuals undergoing spine surgery.

Conditions

  • Scoliosis
  • Kyphosis
  • Lordosis
  • Spondylitis
  • Spinal Stenosis

Interventions

DRUG

Epsilon-Aminocaproic Acid (EACA)

Participants will receive EACA intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).

DRUG

Placebo

Participants will receive placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Sean Berenholtz, MD, MHS · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2006-02-28
Completion
2006-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00320619 on ClinicalTrials.gov