Evaluation of Whole Blood With CPD Anticoagulant and AS-7/SOLX Additive Solution

NCT02145507 | Completed Phase 1 Results

• 1 other identifier: TP-CLN-100331
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 2

Brief Summary

This study will evaluate a new blood collection and filtration system that is intended to be used to collect, filter, separate and store red blood cells and, separately, plasma. The new blood collection and filtration system will be compared to an already-approved and currently used system. Further, this study will evaluate new processing conditions relative to the individual components of the collection and filtration system. All study participants will donate two units of whole blood with individual units being donated at least 56 days apart. One unit of whole blood will be donated with the new system, and the other unit will be collected with the already-approved system. A subset of the donors (approximately 24 of the 120 participants) will have a small quantity of their red blood cells injected back into their body 42-days after they were donated in order to evaluate how well the red blood cells survive. Blood and blood products from all donors will be analyzed the day of collection and after storage (plasma after at least 30 days of storage and red blood cells after exactly 42 days of storage).

Conditions

Blood Donors

Keywords

Leukoreduction; Red Blood Cell post-leukoreduction recovery; Packed red blood cell post storage hemolysis; Red blood cell recovery; Plasma clotting factors; 2,3-DPG rejuvenation

Outcome Measures

Primary Outcomes (2)

• Red Blood Cell Post-filtration Recovery

  The percent of recovered red blood cells when the content of pre-filtration whole blood is compared to the post-filtration leukoreduced whole blood content.

  Arm and product dependent (< 8 hours, 20-24 hours, 66-72 hours post collection)

• Residual Leukocyte Count

  The level of residual white blood cells in whole blood filtered after either \<8 hours (AS-3) or 20-24hours (SOLX) of room temperature storage or cold storage for 72 hours.

  <8 hours and 20-24 hours

Study Arms (2)

Arm 1: Room Temperature Storage/Filtration

OTHER

SOLX (Investigational Product) and AS-3 (Control)

Drug: SOLX (Investigational); Drug: AS-3 (Control)

Arm 2 : Cold storage

OTHER

SOLX (Investigational Product) and AS-3 (Control)

Drug: SOLX (Investigational); Drug: AS-3 (Control)

Interventions

SOLX (Investigational) DRUG

SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.

Also known as: AS-7, Additive solution 7

Arm 1: Room Temperature Storage/Filtration; Arm 2 : Cold storage

AS-3 (Control) DRUG

AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit

Also known as: Additive solution formula 3

Arm 1: Room Temperature Storage/Filtration; Arm 2 : Cold storage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age - Study donor must be ≥ 18 years of age
• Weight - Study donor must be ≥ 110 pounds
• Temperature - Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral)
• Hemoglobin - Study donor's hemoglobin must be ≥12.5 g/dL
• Hematocrit - Study donor's hematocrit must be ≥ 38%. Donor Eligibility - Study donor must meet all criteria per respective site's Research Blood Donation Record (BDR)
• Prior Donation - Study donor's most recent single RBC unit donation must have been ≥56 days prior to study donation. Study donor's most recent double RBC unit donation must have been ≥ 112 days prior to study donation
• Informed Consent - Study donor must have consented to study participation by reviewing and having expressed understanding the site-respective IRB-approved informed consent form prior to undergoing any study related procedures
• Blood-borne Pathogens - Study donor's testing results from collected blood does not indicate a risk of transfusion-transmitted disease (TTD)
• Adverse Events - Study donors must agree to report adverse events from the time of signing the informed consent to twenty-four hours following the end of their active study involvement
• Pregnancy - Female study donors must not be pregnant, expected to be pregnant or breastfeeding. Only female donors who participate in the in vivo portion of the study: Women of child-bearing age must not be pregnant as determined by a negative pregnancy test prior to each re-infusion. If acceptable by local procedures, post-menopausal or surgically sterile women may be exempt from the pregnancy testing requirement

You may not qualify if:

• Failure to meet one or more of the above criteria

Sponsors & Collaborators

• Haemonetics Corporation: lead

Study Sites (2)

Hoxworth Blood Center

Cincinnati, Ohio, 45267, United States

Location

American Red Cross Mid-Atlantic Region Blood Services

Norfolk, Virginia, 23507, United States

Location

Limitations and Caveats

The evaluable population is defined as any blood donation from which a full unit of blood was obtained. Note that the 'evaluability' status could change over time if a sample was inadvertently destroyed, overlooked or otherwise could not be analyzed

Results Point of Contact

• Title: Adrian Orr, Clinical Research Director
• Organization: Haemonetics (trial sponsor)

aorr@haemonetics.com

781.356.9647

Study Officials

• Lou A Maes, MD

  ARC Mid-Atlantic Region Blood Services

  PRINCIPAL INVESTIGATOR

• Jose Cancelas, MD

  Hoxworth Blood Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 23, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 25, 2022
• Results First Posted: March 28, 2022

Record last verified: 2022-03

Locations

US (2)