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Blood Transfusion, AutologousNCT01226498

Effects of Blood Transfusion in Healthy Volunteers

A study testing Red blood Cells auto-transfusion in people with Blood Transfusion, Autologous, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to assess effects of the storage of PRBC on endothelial function, inflammation and platelet activation in healthy volunteers Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Blood Transfusion, Autologous
What is being tested?
Red blood Cells auto-transfusion
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Jul 2010to Feb 2011
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 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Have a photo ID
  • Body mass index (BMI) <25 kg/m2 and >18 kg/m2
  • Fasting for 8 hours prior to enrollment in the study (a sip of water or brushing teeth in the morning are allowed)
  • Feel well the day of blood donation
  • Normal physical exam and normal blood test as indicated:
  • WBC 4.5-11.0 th/cmm
Show all 17Show fewer
  • HGB 12.5-17.5 gm/dl
  • PLT 150-400 th/cumm
  • Plasma Sodium 135-145 mmol/L
  • Plasma Potassium 3.4-4.8 mmol/L
  • Plasma Chloride 98-108 mmol/L
  • Plasma Carbon Dioxide 23.0-31.9 mmol/L
  • Plasma Urea Nitrogen 8-25 mg/dl
  • Plasma Creatinine 0.60-1.50 mg/dl
  • Plasma Glucose 70-110 mg/dl
  • Transaminase-SGPT 10-55 U/L
  • Transaminase-SGOT 10-40 U/L

Who cannot join

  • Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year
  • Systemic disease with or without any functional limitation
  • controlled hypertension
  • controlled diabetes without systemic effects
  • Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin (hCG), or less than six weeks postpartum
  • Active smoking. Volunteers may be enrolled if they quit smoking for more than 1 year
Show all 14Show fewer
  • Excess alcohol use: more than ½ L/day of wine consumption or equivalent
  • Any current use of a medication other than: Over-the-counter oral medications, herbal remedies, nutritional supplements, and oral contraceptives
  • Antibiotic use within 48 hours of blood donation
  • Use of NSAIDS, corticosteroids, aspirin during the past 7 days
  • Dental work within 24 hours prior to the donation
  • Received or donated blood in the last 4 months
  • Have had any forms of cancer with the exceptions of basal cell skin cancer or treatment for in situ cervical cancer
  • Currently enrolled in another research study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital (MGH)

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Effects of Duration of Stored Red Blood Cell Transfusion on Physiological Parameters and Inflammatory Mediators in Healthy Adult Volunteers

The objective of this study is to assess effects of the storage of PRBC on endothelial function, inflammation and platelet activation in healthy volunteers

Read the detailed description

The objective of this study is to assess effects of the storage of PRBC on endothelial function, inflammation and platelet activation in healthy volunteers.

The present study consists of two parts. During one phase of the study, 10 healthy human volunteers will donate a unit of blood, which will be leukoreduced and stored in Additive Solutions-1 (AS-1), and then transfused back to the subjects after 2 days of storage at 4º C in the MGH Blood Bank. The other part of the study consists in the collection of a unit of blood from the same volunteers, but which will be transfused back to the same subject after 40 days of storage. There will be a break of 2 week period in between these 2 study phases. The order of these 2 study parts will be randomized.

We hypothesize that old red blood cells stored under conventional conditions may trigger a complex, pro-inflammatory, pro-thrombotic and vasoconstriction response. We will compare the response to PRBC stored for 2 days with the response to PRBC stored for 40 days in the same healthy volunteers. We will monitor/measure the following markers/parameters:

  1. Endothelium-mediated changes in vascular (arterial) tone
  2. Tissue oxygen saturation will be continuously assessed during and after blood transfusion
  3. Hemolysis as quantified by changes in plasma haptoglobin level, plasma free hemoglobin, LDH level, bilirubin level, iron level, ferritin, and transferrin
  4. Changes of plasma and red blood cell levels of circulating nitrate, nitrite, RXNO, RNNO, NO-heme
  5. Concentration of cytokines, such as IL-6, IL-8, IL-10, IL-12, TNF, IFN-γ
  6. Activation of platelets through circulating P-selectin expression on platelets
  7. Activation of inflammatory lipid mediators
  8. Changes in gene expression profiling analyzing RNA microarray of circulating leukocytes
Being tested
Red blood Cells auto-transfusion
Keywords
Blood Transfusion, Autologous, Blood Preservation/adverse effects, Blood Transfusion/adverse effects, Endothelium, Vascular/physiopathology, Inflammation Mediators

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Red blood Cells auto-transfusionProcedure or surgery

    Withdrawal from 10 Healthy volunteers of one unit of red blood cells and auto-transfusion after 3 days for one arm of the study, after 40 days for the other. Participants are enrolled in both arms of the study.

Study groups in NCT01226498
Study groupRoleWhat they receive
Fresh blood auto-transfusionExperimentalNot described
Receives: Procedure: Red blood Cells auto-transfusion
Old blood auto-transfusionExperimentalNot described
Receives: Procedure: Red blood Cells auto-transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endothelial function

    Measured: Baseline

  2. Endothelial function

    Measured: 10 min after transfusion

  3. Endothelial function

    Measured: 1h after transfusion

  4. Endothelial function

    Measured: 4h after transfusion

Secondary outcomes (30)

  1. Hemolysis

    Measured: Baseline

  2. NO metabolites

    Measured: Baseline

  3. Concentration of cytokines

    Measured: Baseline

  4. Activation of platelets

    Measured: Baseline

  5. Activation of inflammatory lipid mediators

    Measured: Baseline

  6. Changes in gene expression

    Measured: Baseline

  7. Hemolysis

    Measured: 10 min after transfusion

  8. NO metabolites

    Measured: 10 min after transfusion

  9. Concentration of cytokines

    Measured: 10 min after transfusion

  10. Activation of platelets

    Measured: 10 min after transfusion

  11. Activation of inflammatory lipid mediators

    Measured: 10 min after transfusion

  12. Changes in gene expression

    Measured: 10 min after transfusion

  13. Hemolysis

    Measured: 1h after transfusion

  14. NO metabolites

    Measured: 1h after transfusion

  15. Concentration of cytokines

    Measured: 1h after transfusion

  16. Activation of platelets

    Measured: 1h after transfusion

  17. Activation of inflammatory lipid mediators

    Measured: 1h after transfusion

  18. Changes in gene expression

    Measured: 1h after transfusion

  19. Hemolysis

    Measured: 2h after transfusion

  20. NO metabolites

    Measured: 2h after transfusion

  21. Concentration of cytokines

    Measured: 2h after transfusion

  22. Activation of platelets

    Measured: 2h after transfusion

  23. Activation of inflammatory lipid mediators

    Measured: 2h after transfusion

  24. Changes in gene expression

    Measured: 2h after transfusion

  25. Hemolysis

    Measured: 4h after transfusion

  26. NO metabolites

    Measured: 4h after transfusion

  27. Concentration of cytokines

    Measured: 4h after transfusion

  28. Activation of platelets

    Measured: 4h after transfusion

  29. Activation of inflammatory lipid mediators

    Measured: 4h after transfusion

  30. Changes in gene expression

    Measured: 4h after transfusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionNov 2010
  4. Study completionFeb 2011

Resources

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
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01226498
Sponsor's protocol ID
2010P000961
Status last verified
Jan 2014
First submitted
14 Oct 2010
Last updated
30 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Hendrickson JE, Hillyer CD. Noninfectious serious hazards of transfusion. Anesth Analg. 2009 Mar;108(3):759-69. doi: 10.1213/ane.0b013e3181930a6e.

    PubMed 19224780

  • Koch CG, Li L, Sessler DI, Figueroa P, Hoeltge GA, Mihaljevic T, Blackstone EH. Duration of red-cell storage and complications after cardiac surgery. N Engl J Med. 2008 Mar 20;358(12):1229-39. doi: 10.1056/NEJMoa070403.

    PubMed 18354101

  • Bennett-Guerrero E, Veldman TH, Doctor A, Telen MJ, Ortel TL, Reid TS, Mulherin MA, Zhu H, Buck RD, Califf RM, McMahon TJ. Evolution of adverse changes in stored RBCs. Proc Natl Acad Sci U S A. 2007 Oct 23;104(43):17063-8. doi: 10.1073/pnas.0708160104. Epub 2007 Oct 11.

    PubMed 17940021

  • Cardillo C, Kilcoyne CM, Cannon RO 3rd, Panza JA. Interactions between nitric oxide and endothelin in the regulation of vascular tone of human resistance vessels in vivo. Hypertension. 2000 Jun;35(6):1237-41. doi: 10.1161/01.hyp.35.6.1237.

    PubMed 10856270

  • Panza JA, Casino PR, Kilcoyne CM, Quyyumi AA. Role of endothelium-derived nitric oxide in the abnormal endothelium-dependent vascular relaxation of patients with essential hypertension. Circulation. 1993 May;87(5):1468-74. doi: 10.1161/01.cir.87.5.1468.

    PubMed 8491001

  • Gladwin MT, Lancaster JR Jr, Freeman BA, Schechter AN. Nitric oxide's reactions with hemoglobin: a view through the SNO-storm. Nat Med. 2003 May;9(5):496-500. doi: 10.1038/nm0503-496. No abstract available.

    PubMed 12724752

  • Nagasaka Y, Fernandez BO, Garcia-Saura MF, Petersen B, Ichinose F, Bloch KD, Feelisch M, Zapol WM. Brief periods of nitric oxide inhalation protect against myocardial ischemia-reperfusion injury. Anesthesiology. 2008 Oct;109(4):675-82. doi: 10.1097/ALN.0b013e318186316e.

    PubMed 18813047

Questions about this trial

What is this clinical trial studying?

A study testing Red blood Cells auto-transfusion in people with Blood Transfusion, Autologous, run by Massachusetts General Hospital 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 17 inclusion and 14 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 30 Jan 2014. 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?

Endothelial function (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01226498, which also lists 7 linked publications.

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 30 Jan 2014.

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