The Safety of Autologous Lyophilized Plasma Versus Fresh Frozen Plasma in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

A single-site, single-blind study of ascending doses of Lyophilized Plasma in normal healthy volunteers.

Key facts

Study ID: NCT00968487
Run by: HemCon Medical Technologies, Inc
People needed: 16
Starts: 2010-06-01
Expected to finish: 2011-12-01
Last updated by the study team: 2012-02-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Males and non-pregnant/ non-breast feeding females as they present interest
Minimum weight, 140 pounds (64 kg) or 175 pounds for Cohort 3 only
Ages 18-55 years
Subject self-reports that he/she feels well and healthy
Subject is able to donate one unit of whole blood based on the AABB donor history questionnaire with modifications indicated. Volunteers with history of travel which puts them at risk for vCJD will be eligible to participate.
Has read the educational materials on donating blood and has had his/her questions answered
Able and willing to provide informed consent
Available for the duration of the trial (approximately 8 weeks for Cohorts 1 and 2 and 12 weeks for Cohort 3) and able to come to the treatment clinic for scheduled study visits.
Females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen. A highly effective method of birth control is defined as those which result in a lower failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner.
Female subjects must have a negative serum pregnancy test prior to enrollment.
Understands the English language
Scored greater or equal to 35 on the Duke Activity Status Index (DSAI)

You may not qualify if…

Known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood, endocrine/ metabolic, autoimmune or pulmonary disease; treated or untreated hypertension (see precise cut-off below)
Cancer of any kind, under treatment or resolved
Known or past coagulopathy conditions or blood disease
Currently using medications for anticoagulant therapy
Currently taking fish oil supplements
Any conditions, medications, etc. on the AABB medical deferral list
Previous use of clotting factor concentrate(s)
Past diagnosis of stroke or transient ischemic attack
Current or history of drug or alcohol abuse. Used needles to take drugs, steroids, or anything not prescribed by a doctor
Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness or received a positive test result for HIV infection.
Current or past infection with Hepatitis B or Hepatitis C virus
Has received positive test for Syphilis
Has received positive test for West Nile Virus
Female subject who is pregnant, lactating or with a positive pregnancy test
Currently taking an antibiotic or another medication for an infection.
Treatment or use of aspirin (or other platelet inhibiting agents) within 14 days of study donation and infusion visits
In the past week, has had a headache and fever at the same time.
Known intolerance to citric acid.
Receipt of blood or blood products within the past 12 months
Systolic blood pressure greater than 180 mmHg
Diastolic blood pressure greater than 90 mmHg
Temperature greater than 100° F
Hematocrit will not be less than 38% for both male and female donors
History of current mental or psychiatric condition
Treatment with any investigational agent within one month before treatment application for this trial

Where it is running

Hoxworth Blood Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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