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Effects of Blood Transfusion in Healthy Volunteers

29. januar 2014 opdateret af: Warren M. Zapol, Massachusetts General Hospital

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital (MGH)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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
  • Transaminase-SGPT 10-55 U/L
  • Transaminase-SGOT 10-40 U/L

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Fresh blood auto-transfusion
Procedure: Red blood Cells auto-transfusion
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.
Eksperimentel: Old blood auto-transfusion
Procedure: Red blood Cells auto-transfusion
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Endothelial function
Tidsramme: Baseline
Baseline
Endothelial function
Tidsramme: 10 min after transfusion
10 min after transfusion
Endothelial function
Tidsramme: 1h after transfusion
1h after transfusion
Endothelial function
Tidsramme: 4h after transfusion
4h after transfusion

Sekundære resultatmål

Resultatmål
Tidsramme
Hemolysis
Tidsramme: Baseline
Baseline
NO metabolites
Tidsramme: Baseline
Baseline
Concentration of cytokines
Tidsramme: Baseline
Baseline
Activation of platelets
Tidsramme: Baseline
Baseline
Activation of inflammatory lipid mediators
Tidsramme: Baseline
Baseline
Changes in gene expression
Tidsramme: Baseline
Baseline
Hemolysis
Tidsramme: 10 min after transfusion
10 min after transfusion
NO metabolites
Tidsramme: 10 min after transfusion
10 min after transfusion
Concentration of cytokines
Tidsramme: 10 min after transfusion
10 min after transfusion
Activation of platelets
Tidsramme: 10 min after transfusion
10 min after transfusion
Activation of inflammatory lipid mediators
Tidsramme: 10 min after transfusion
10 min after transfusion
Changes in gene expression
Tidsramme: 10 min after transfusion
10 min after transfusion
Hemolysis
Tidsramme: 1h after transfusion
1h after transfusion
NO metabolites
Tidsramme: 1h after transfusion
1h after transfusion
Concentration of cytokines
Tidsramme: 1h after transfusion
1h after transfusion
Activation of platelets
Tidsramme: 1h after transfusion
1h after transfusion
Activation of inflammatory lipid mediators
Tidsramme: 1h after transfusion
1h after transfusion
Changes in gene expression
Tidsramme: 1h after transfusion
1h after transfusion
Hemolysis
Tidsramme: 2h after transfusion
2h after transfusion
NO metabolites
Tidsramme: 2h after transfusion
2h after transfusion
Concentration of cytokines
Tidsramme: 2h after transfusion
2h after transfusion
Activation of platelets
Tidsramme: 2h after transfusion
2h after transfusion
Activation of inflammatory lipid mediators
Tidsramme: 2h after transfusion
2h after transfusion
Changes in gene expression
Tidsramme: 2h after transfusion
2h after transfusion
Hemolysis
Tidsramme: 4h after transfusion
4h after transfusion
NO metabolites
Tidsramme: 4h after transfusion
4h after transfusion
Concentration of cytokines
Tidsramme: 4h after transfusion
4h after transfusion
Activation of platelets
Tidsramme: 4h after transfusion
4h after transfusion
Activation of inflammatory lipid mediators
Tidsramme: 4h after transfusion
4h after transfusion
Changes in gene expression
Tidsramme: 4h after transfusion
4h after transfusion

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Massachusetts General Hospital

Efterforskere

  • Ledende efterforsker: Warren M Zapol, MD, Massachusetts General Hospital, DACCPM

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2010

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. februar 2011

Datoer for studieregistrering

Først indsendt

14. oktober 2010

Først indsendt, der opfyldte QC-kriterier

20. oktober 2010

Først opslået (Skøn)

22. oktober 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. januar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2010P000961

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Blodtransfusion, autolog

Kliniske forsøg med Red blood Cells auto-transfusion

Søg i lignende forsøg

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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