Assessment of Whole Blood Cold Stored Platelets

NCT02006368 | Completed

• 2 other identifiers: 12-10W81XWH-12-1-0441, EDMS 5570
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the life span and functional characteristics of platelets derived from whole blood that has been stored in a refrigerator for up to 21 days. Currently, platelets are separated from red cells shortly after donation and stored at room temperature for no longer than 5 days. This study is considered experimental because; 1) we will be keeping platelets in the original whole blood donor unit in the refrigerator, and 2) we will be reinfusing a small portion of that donation back into the study-subject-donor and tracking how many of the transfused platelets from that unit circulate in the study-subject-donor in the hours and days after transfusion.

Conditions

Healthy

Keywords

Volunteers; Blood Platelets; Platelet Transfusion

Outcome Measures

Primary Outcomes (1)

• To determine the relationship between each donor's fresh and stored platelet recoveries.

  The primary endpoint of this study will be to determine the relationship between each donor's fresh and stored platelet recoveries. The lower 95% confidence limit for the data should be that platelet recoveries at the end of storage should be ≥50% of fresh and survivals should be ≥ 1 day.

  Whole blood units will be held for 4-20 days at 4 degrees C, assigned at consent.

Study Arms (1)

Storage Age

EXPERIMENTAL

Other: Blood Collection and autologous re-infusion

Interventions

Blood Collection and autologous re-infusion OTHER

Subjects will donate one unit of whole blood. This unit will be stored at 4°C for a predefined storage period. A variety of in vitro metabolic and functional platelet assays will be performed on the stored unit. After the storage period, an aliquot from the whole blood unit will be processed to obtain platelets. The subject will return and donate a fresh sample of whole blood (43 mls) from which a fresh aliquot of platelets will be obtained. The stored and fresh platelets will each be labeled with a different radioisotope (either Chromium-51 or Indium-111) and reinfused into the subject. Using two different radioisotopes enables separate tracking of both the stored and fresh platelets. Follow-up blood samples will be drawn at 2 hours and on days 1, 2, 3, 5, 7±1 and 10±2. Stored and Fresh platelet recoveries and survivals will be calculated.

Storage Age

Eligibility Criteria

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

You may qualify if:

• The subject is in good health, is taking no excluded medications, and satisfies the Blood Center's criteria to donate blood products. Criteria will also include the following guidelines:
• Meets whole blood/platelet donor suitability requirements as defined in 21 CFR 640.3 and set forth by the AABB (Reference Standard 5.4.1A, 2006). Past travel restrictions do not apply for this study.
• Weight ≥50 kg (110 pounds)
• Hemoglobin/hematocrit: ≥12.5 g/dL/38%
• Temperature: less than or equal to 37.5 degrees C
• Resting blood pressure: systolic less than or equal 180 mmHg; diastolic ≥100 mmHg
• Resting heart rate: 50 to 100 beats per minute
• Age ≥ 18 years, of either sex;
• Able to read, understand and sign the informed consent document and commit to the study follow-up schedule;
• Subjects must have good veins for whole blood collection and follow-up blood draws;
• Subjects of child-bearing potential must agree to use an effective contraceptive during the course of the study;
• Those subjects who will be reinfused within 10 days of their 500 mL WB collection must meet the criteria for donating a double RBC unit to accommodate the sampling volume that will occur shortly thereafter:
• Male subjects must weigh a minimum of 130 lbs and be at least 5'1" tall
• Female subjects must weigh a minimum of 150 lbs and be at least 5'5" tall
• Both male and female subjects must have a Hematocrit of ≥ 40%;

You may not qualify if:

• Any serious medical illness and/or therapy, including: abnormal bleeding episodes, clotting or bleeding disorder, evidence of anemia, myocardial infarction, uncontrolled hypertension, heart disease, surgery with bleeding complications, epilepsy or any major surgery (with general or spinal anesthesia) within the last 6 months;
• Taking aspirin, Alka-Seltzer™, clopidogrel, or other "anti-platelet" drugs within 7 days prior to donation.
• Taking any nonsteroidal anti-inflammatory drug (for example: Motrin™, Advil™, or ibuprofen) within 3 days prior to donation.
• Taking any anticoagulant medications (for example Coumadin, dabigatran, rivaroxaban or any medications chemically related to heparin).
• Currently pregnant or nursing within the 6 weeks prior to enrollment as assessed during interview. Current status is confirmed by pregnancy test prior to radioisotope infusion.
• Inability to comply with the protocol in the opinion of the investigator.
• Participation in another investigational trial that would potentially interfere with the analysis of this investigation (e.g., pharmaceutical);
• Have participated in ≥ 4 research studies involving radioisotopes within the last 12 months.

Sponsors & Collaborators

• Bloodworks: lead
• United States Department of Defense: collaborator

Study Sites (1)

Puget Sound Blood Center

Seattle, Washington, 98104, United States

Location

Study Officials

• Sherrill J Slichter, MD

  Puget Sound Blood Center & University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 10, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 4, 2017

Record last verified: 2017-08

Locations

US (1)