HealthyBrrrNCT02006368
Assessment of Whole Blood Cold Stored Platelets
A study testing Blood Collection and autologous re-infusion in people with Healthy, run by Bloodworks at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Blood Collection and autologous re-infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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%;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Subjects will be enrolled for evaluation of platelet recovery and survival. Healthy subjects will be consented and enrolled into the study until 8 subjects have completed the recovery and survival evaluations at 4, 8, 12, 16, and 20 days storage. The order in which storage intervals are evaluated will be randomized. Eight subjects will then be evaluated at the mid-range interval between longest storage period that meets acceptances criteria and shortest storage period that does not meet acceptance criteria. For instance, if at 12 days of storage the 95% lower confidence limits for recoveries are NOT ≥50% of fresh and survivals are LESS than one day, but at 8 days of storage recoveries are ≥50% of fresh and survivals are at least than one day, we will then evaluate 10 days of storage. If the 10 day storage does not meet acceptance criteria we will evaluate 9 days. If the 10 day storage does meet acceptance criteria we will evaluate 11 days. Eight subjects will be evaluated at each storage interval.
Subjects will donate one unit of whole blood. This unit will be maintained as whole blood in CPD (Citrate Phosphate Dextrose anticoagulant) not leukoreduced and not separated into components. These WB units will be stored under refrigerated conditions (4°C) for between 4 and 20 days after collection. Prior to refrigeration samples from the unit will be obtained for various in vitro tests.
In vivo Measurements:
At the end of each subject's storage period a ~200 mL aliquot of whole blood will be withdrawn from the unit. This aliquot will be centrifuged and the platelets extracted. The platelets will be radiolabeled with 51-Cr or 111-In. On that day, the subject will return to the Blood Center and provide a 43 mL fresh blood sample. Platelets from that sample will be harvested and labeled with the other isotope. Radiolabeling will be done by the BEST method. These aliquots will be sequentially infused into the subject. The estimated amount of the isotope is ≤15 μCi of indium and ≤20 μCi of chromium will be infused. The total radiation dose is approximately 40 μCi for a total body absorbed dose of 0.0273 rad (0.273 mSv) and a splenic absorbed dose of 3.2 rad (32 mSv). Venous samples (10 mls/draw) will be taken within 2 hours after reinfusion and on days 1, 2, 3, 5, 7 ± 1, and 10 ± 2. After these visits, the subject's participation will end and they will exit the study. Stored and fresh platelet recoveries and survivals will be determined and comparisons will be made between each subject's fresh and stored platelet recoveries.
In vitro Assays:
The following assays will be performed using a 50 ml sample obtained from the whole blood pre and post storage:
- platelet count
- platelet function assays (mean platelet volume, morphology score, hypotonic shock response, extent of shape change, pH, PO2, PC02, HC03, glucose and lactate. Platelet aggregation response to standard agonists (ADP, collagen, arachidonic acid) will also be measured.
- platelet activation and apoptotic markers (p-selectin antigen, annexin V, platelet microparticles)
- thrombelastograph
- thrombin generation test
- plasma analysis of coagulation, complement, microparticles and fibrinolytic potential (thrombin-antithrombin complex (TAT), plasmin-antiplasmin complex (PAP), soluble cd 40l, plasminogen activator inhibitor (PAI-1 ), complement (C3a, C4d, C5b-9)
- sterility - bacterial cultures will be submitted after collection and the results evaluated 14 days later, or sooner if blood is stored for a shorter time period. A gram stain will be performed on the isolated 4° C platelets before reinfusion at the end of storage. All sterility tests must be negative before test platelets will be reinfused.
- Conditions
- Healthy
- Being tested
- Blood Collection and autologous re-infusion
- Keywords
- Volunteers, Blood Platelets, Platelet Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Collection and autologous re-infusionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Storage Age | Experimental | Not described Receives: Other: Blood Collection and autologous re-infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Whole blood units will be held for 4-20 days at 4 degrees C, assigned at consent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bloodworks
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Sherrill J Slichter, MD, Principal investigator, Puget Sound Blood Center & University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006368
- Sponsor's protocol ID
- 12-10
- Other IDs
- W81XWH-12-1-0441, EDMS 5570
- Acronym
- Brrr
- Status last verified
- Aug 2017
- First submitted
- 5 Dec 2013
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Whole Blood Cold Stored Platelets
- ClinicalTrials.gov ID
- NCT02006368
- Acronym / sponsor ID
- Brrr / 12-10
- Conditions
- Healthy
- Keywords
- Volunteers, Blood Platelets, Platelet Transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- BloodworksUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects will be enrolled for evaluation of platelet recovery and survival. Healthy subjects will be consented and enrolled into the study until 8 subjects have completed the recovery and survival evaluations at 4, 8, 12, 16, and 20 days storage. The order in which storage intervals are evaluated will be randomized. Eight subjects will then be evaluated at the mid-range interval between longest storage period that meets acceptances criteria and shortest storage period that does not meet acceptance criteria. For instance, if at 12 days of storage the 95% lower confidence limits for recoveries are NOT ≥50% of fresh and survivals are LESS than one day, but at 8 days of storage recoveries are ≥50% of fresh and survivals are at least than one day, we will then evaluate 10 days of storage. If the 10 day storage does not meet acceptance criteria we will evaluate 9 days. If the 10 day storage does meet acceptance criteria we will evaluate 11 days. Eight subjects will be evaluated at each storage interval.
Subjects will donate one unit of whole blood. This unit will be maintained as whole blood in CPD (Citrate Phosphate Dextrose anticoagulant) not leukoreduced and not separated into components. These WB units will be stored under refrigerated conditions (4°C) for between 4 and 20 days after collection. Prior to refrigeration samples from the unit will be obtained for various in vitro tests.
In vivo Measurements:
At the end of each subject's storage period a ~200 mL aliquot of whole blood will be withdrawn from the unit. This aliquot will be centrifuged and the platelets extracted. The platelets will be radiolabeled with 51-Cr or 111-In. On that day, the subject will return to the Blood Center and provide a 43 mL fresh blood sample. Platelets from that sample will be harvested and labeled with the other isotope. Radiolabeling will be done by the BEST method. These aliquots will be sequentially infused into the subject. The estimated amount of the isotope is ≤15 μCi of indium and ≤20 μCi of chromium will be infused. The total radiation dose is approximately 40 μCi for a total body absorbed dose of 0.0273 rad (0.273 mSv) and a splenic absorbed dose of 3.2 rad (32 mSv). Venous samples (10 mls/draw) will be taken within 2 hours after reinfusion and on days 1, 2, 3, 5, 7 ± 1, and 10 ± 2. After these visits, the subject's participation will end and they will exit the study. Stored and fresh platelet recoveries and survivals will be determined and comparisons will be made between each subject's fresh and stored platelet recoveries.
In vitro Assays:
The following assays will be performed using a 50 ml sample obtained from the whole blood pre and post storage:
- platelet count
- platelet function assays (mean platelet volume, morphology score, hypotonic shock response, extent of shape change, pH, PO2, PC02, HC03, glucose and lactate. Platelet aggregation response to standard agonists (ADP, collagen, arachidonic acid) will also be measured.
- platelet activation and apoptotic markers (p-selectin antigen, annexin V, platelet microparticles)
- thrombelastograph
- thrombin generation test
- plasma analysis of coagulation, complement, microparticles and fibrinolytic potential (thrombin-antithrombin complex (TAT), plasmin-antiplasmin complex (PAP), soluble cd 40l, plasminogen activator inhibitor (PAI-1 ), complement (C3a, C4d, C5b-9)
- sterility - bacterial cultures will be submitted after collection and the results evaluated 14 days later, or sooner if blood is stored for a shorter time period. A gram stain will be performed on the isolated 4° C platelets before reinfusion at the end of storage. All sterility tests must be negative before test platelets will be reinfused.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Storage Age | Experimental | Other: Blood Collection and autologous re-infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Collection and autologous re-infusionSubjects 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. | Other | Storage Age |
Primary outcome
To determine the relationship between each donor's fresh and stored platelet recoveries.
Time frame: Whole blood units will be held for 4-20 days at 4 degrees C, assigned at consent.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherrill J Slichter, MD principal investigator
Puget Sound Blood Center & University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Collection and autologous re-infusion in people with Healthy, run by Bloodworks at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the relationship between each donor's fresh and stored platelet recoveries. (time frame: Whole blood units will be held for 4-20 days at 4 degrees C, assigned at consent.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.