Evaluation of Therapeutic Plasma Exchan… | Clinical Trial

Key information

Conditions

Autoimmune Diseases Blood Protein Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hematologic Disorders Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Kidney Diseases Male Urogenital Diseases Nervous System Diseases Oncologic Disorders Paraproteinemias Renal Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yale University School of Medicine, New Haven, Connecticut, United States

About this study

Therapeutic plasma exchange (TPE) is intended for efficient removal of circulating plasma, with the return of replacement fluids to the patient. In the majority of cases, the treatment goal is to selectively remove the substance directly responsible for the patient's disease process.

Fenwal's AMICUS separator platform is a centrifuge-based apheresis system which collects the blood components of interest and returns the remaining blood components along with saline back to a donor/patient. The device has been cleared for the following:

The collection of platelets and plasma in Japan, Europe and the US (BK960005), 1996.
The collection of mononuclear cells (MNCs) in the US (BK000047), 2002.
The collection of a concurrent red blood cell (cRBC) product collected in ACD-A anticoagulant and stored in ADSOL® Preservation Solution (BK000039), 2002.

Fenwal has developed a new protocol on the AMICUS separator that enables the device to perform TPE procedures. The procedure is similar to the FDA cleared platelet and concurrent plasma collections, except that in TPE procedures the majority of plasma is retained and the red blood cells (RBCs), white blood cells (WBC) and the majority of the platelets are returned to the patient.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Medically stable patients undergoing more than one TPE procedure who have provided signed informed consent prior to participation.
A physician's prescription for TPE for various non-emergent conditions.
Test and Control TPE procedures that would be expected to be completed within approximately five weeks.

Exclusion criteria

Patients under 18 years old.
Patients on an ACE inhibitor medication should discontinue use of this medication in accordance with institutional practices.
Patients with altered mental status that would prohibit the giving and understanding of informed consent.
Patients who have experienced a serious adverse event associated with the first TPE clinical study procedure.

Treatment and study plan

Therapeutic plasma exchange

Device

Patients are randomized to either Therapeutic plasma exchange procedures on AMICUS or Spectra first. The second procedure (based on time interval determined by physician) will be completed on the other instrument.

Other names: TPE

Primary outcomes

Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure

Time frame: After completion of the TPE procedure.

The calculation is based on the volume of plasma that was processed through the machine compared to the volume of patient plasma that was actually removed during the procedure.

Plasma Efficiency = (plasma removed/plasma processed)*100

Secondary outcomes

Safety Measured by Adverse Events During the TPE Procedure

Time frame: Adverse events were collected during each TPE procedure.

Sponsors and collaborators

Lead sponsor

Fenwal, Inc.

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Sep 28, 2010
Registry last updated: Sep 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed