Effects of Blood Transfusion in Healthy Volunteers

NCT01226498 | Completed DMC

• 1 other identifier: 2010P000961
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Blood Transfusion, Autologous

Keywords

Blood Transfusion, Autologous; Blood Preservation/adverse effects; Blood Transfusion/adverse effects; Endothelium, Vascular/physiopathology; Inflammation Mediators

Outcome Measures

Primary Outcomes (4)

• Endothelial function

  Baseline

• Endothelial function

  10 min after transfusion

• Endothelial function

  1h after transfusion

• Endothelial function

  4h after transfusion

Secondary Outcomes (30)

• Hemolysis

  Baseline

• NO metabolites

  Baseline

• Concentration of cytokines

  Baseline

• Activation of platelets

  Baseline

• Activation of inflammatory lipid mediators

  Baseline

Study Arms (2)

Fresh blood auto-transfusion

EXPERIMENTAL

Procedure: Red blood Cells auto-transfusion

Old blood auto-transfusion

EXPERIMENTAL

Procedure: Red blood Cells auto-transfusion

Interventions

Red blood Cells auto-transfusion PROCEDURE

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.

Fresh blood auto-transfusion; Old blood auto-transfusion

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02114, United States

Location

Related Publications (7)

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

  PMID: 19224780 BACKGROUND

• 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.

  PMID: 18354101 BACKGROUND

• 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.

  PMID: 17940021 BACKGROUND

• 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.

  PMID: 10856270 BACKGROUND

• 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.

  PMID: 8491001 BACKGROUND

• 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.

  PMID: 12724752 BACKGROUND

• 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.

  PMID: 18813047 BACKGROUND

Study Officials

• Warren M Zapol, MD

  Massachusetts General Hospital, DACCPM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 22, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: February 1, 2011
• Last Updated: January 30, 2014

Record last verified: 2014-01

Locations

US (1)