NCT01529502

Brief Summary

The purpose of this study is to determine whether storage time affects how human body responds to autologous blood transfusion. An autologous blood transfusion is when a person donates blood and then receives that same blood back in the transfusion. We also want to find out if in this situation inhaled nitric oxide can help to prevent the potential reduction of vasodilation capacity. Vasodilation capacity is the ability of the blood vessel to widen when needed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

March 29, 2017

Completed
Last Updated

May 22, 2017

Status Verified

April 1, 2017

Enrollment Period

1.8 years

First QC Date

February 6, 2012

Results QC Date

October 26, 2016

Last Update Submit

April 17, 2017

Conditions

Blood TransfusionEndothelial PhysiopathologyNitric OxidePulmonary Hypertension

Keywords

Blood Transfusion, AutologousBlood Preservation/adverse effectsBlood Transfusion/adverse effectsEndothelium, Vascular/physiopathologyHemoglobinsNitric OxidePulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Systolic Pulmonary Artery Pressure

    Pulmonary vasoconstriction was measured by estimation of Systolic Pulmonary Artery Pressure in millimeter of mercury (mmHg) by trans-thoracic echocardiography

    Post-transfusion

Secondary Outcomes (1)

  • Endothelial Function: Reactive Hyperemia Index

    Post-transfusion

Other Outcomes (7)

  • Hemolysis

    before and after blood transfusion

  • Nitric Oxide Metabolites

    Before and after blood transfusion

  • Concentration of Cytokines

    Before and after blood transfusion

  • +4 more other outcomes

Study Arms (3)

Fresh blood

EXPERIMENTAL
Procedure: Red blood Cells auto-transfusion

Old blood

EXPERIMENTAL
Procedure: Red blood Cells auto-transfusion

Old blood + inhaled Nitric Oxide

EXPERIMENTAL
Procedure: Red blood Cells auto-transfusionDrug: Inhaled Nitric Oxide (iNO) administration

Interventions

Red blood Cells auto-transfusionPROCEDURE

Withdrawal from 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. The same 14 subjects will be included in every arm of the study.

Fresh blood
Inhaled Nitric Oxide (iNO) administrationDRUG

Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion.

Old blood + inhaled Nitric Oxide

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Have a photo ID
  • Age\>18 years old (required to provide informed consent)
  • Age \<60 years old
  • Mild impairment of endothelial function, assessed by post ischemic vasodilation (L\_RHI,\<0.7) (38)
  • Body mass index (BMI) \>27 kg/m\^2 and \<40 kg/m\^2
  • Fasting during the days of transfusion.
  • Avoiding intake of high nitrate food (i.e. green leafy vegetables: lettuce, spinach) on the day prior to the study
  • Feel well on the day of blood donation
  • KG within normal limits
  • Normotensive (systolic blood pressure \<140 mmHg and diastolic \<90 mmHg)
  • Normal physical exam and blood test results as indicated by:
  • WBC 4.5-11.0 n x103/μL
  • HGB 12.0-17.5 gm/dl
  • PLT 150-400 n x103/μL
  • Plasma Sodium 135-145 mmol/L
  • +11 more criteria

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
  • 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 uterine cervical cancer
  • Currently enrolled in another research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

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: 19224780BACKGROUND

  • 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: 18354101BACKGROUND

  • 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: 17940021BACKGROUND

  • 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: 10856270BACKGROUND

  • 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: 8491001BACKGROUND

  • Hod EA, Brittenham GM, Billote GB, Francis RO, Ginzburg YZ, Hendrickson JE, Jhang J, Schwartz J, Sharma S, Sheth S, Sireci AN, Stephens HL, Stotler BA, Wojczyk BS, Zimring JC, Spitalnik SL. Transfusion of human volunteers with older, stored red blood cells produces extravascular hemolysis and circulating non-transferrin-bound iron. Blood. 2011 Dec 15;118(25):6675-82. doi: 10.1182/blood-2011-08-371849. Epub 2011 Oct 20.

    PMID: 22021369BACKGROUND

  • Berra L, Pinciroli R, Stowell CP, Wang L, Yu B, Fernandez BO, Feelisch M, Mietto C, Hod EA, Chipman D, Scherrer-Crosbie M, Bloch KD, Zapol WM. Autologous transfusion of stored red blood cells increases pulmonary artery pressure. Am J Respir Crit Care Med. 2014 Oct 1;190(7):800-7. doi: 10.1164/rccm.201405-0850OC.

    PMID: 25162920DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

InosineOrganization and Administration

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesHealth Services Administration

Results Point of Contact

Title
Dr. Lorenzo Berra
Organization
Massachusetts General Hospital
LBERRA@MGH.HARVARD.EDU
617 724 1901

Study Officials

  • Warren Zapol, MD

    Masachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emeritus Anesthetist-in-Chief and Director of the MGH Anesthesia Center for Critical Care Research, Massachusetts General Hospital; Reginald Jenney Professor of Anesthesia, Harvard Medical School

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 8, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 22, 2017

Results First Posted

March 29, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)