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The Haem and Nitrite Study - The Effects of Haemoglobin NO-blockade on Nitrite-induced Forearm Vessel Dilatation

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ClinicalTrials.gov Identifier: NCT03077763
Recruitment Status : Unknown
Verified March 2017 by University of East Anglia.
Recruitment status was:  Recruiting
First Posted : March 13, 2017
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
University of East Anglia

Brief Summary:
The study is a pharmacodynamic random order cross-over trial investigating the physiological effects of intra-arterial infusion of nitrite following a haemolysed autologous blood transfusion.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Sodium Nitrite Phase 1

Detailed Description:

This is a healthy volunteer study.

Following entry into this cross-over trial, participants will be randomized to undergo experiments under either normoxic followed by hypoxic conditions, or hypoxic followed by normoxic conditions.

Subjects will donate whole blood as an autologous unit at a preselected NHSBT donation site. The unit will transported back to the NNUH blood bank after a minimum of 30 days (maximum 35 days) after donation.

Volunteers will be tested for baseline bloods. Volunteers will be randomised to normoxia or hypoxia. The will then undergo a nitrite infusion, followed by an autologous whole blood transfusion and a second nitrite infusion (which will co-infuse at the end of the transfusion). During the protocol, the participants will undergo repeated FBFR measurements using strain-gauge plethysmography.

After a minimum of 12 weeks rest period after their initial donation, participants will cross-over to the opposite oxygen condition (as per initial randomization) and the above protocol will be repeated. All interventions will be performed by fully trained and competent medical staff.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Free Haemoglobin NO-blockade on Nitrite Forearm Vessel Dilatation Under Normoxia and Hypoxia in Healthy Volunteers
Actual Study Start Date : December 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Active Comparator: Normoxia and Nitrite (3umol/min-1)
Sodium nitrite stock solution: 100umol/10ml, prepared to concentration according to oxygen sequence. Normoxia (3umol/min-1).
Drug: Sodium Nitrite
Active Comparator: Hypoxia and Nitrite (1umol/min-1)
This will be repeated as per the normoxia cohort, but at a reduced dose of sodium nitrite (1umol/min-1 for 30 minutes) and the volunteers will be asked to breathe 12% oxygen/88% nitrogen for 1-5 minutes before Plethysmography is performed (to get the volunteer to an oxygen saturation of 83-88% peripherally).
Drug: Sodium Nitrite



Primary Outcome Measures :
  1. Change in FBFR during intra-brachial nitrite and haemolysed blood co-infusion in normoxia vs hypoxia. [ Time Frame: Up to 18 months ]

Secondary Outcome Measures :
  1. Change in FBFR during haemolysed blood infusion vs baseline [ Time Frame: Up to 18 months ]
  2. Change in FBFR during nitrite infusion in normoxia vs nitrite infusion in hypoxia [ Time Frame: Up to 18 months ]
  3. Change in FBFR during nitrite infusion in normoxia vs baseline [ Time Frame: Up to 18 months ]
  4. Change in FBFR during nitrite infusion in hypoxia vs baseline [ Time Frame: Up to 18 months ]
  5. Blood analysis (cell free haemoglobin, nitrate, nitrite and nitroso species levels) [ Time Frame: Up to 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female, aged greater than or equal to 18 years
  2. If between 18-20 years of age, calculate total blood volume should be more than >3.5L (http://www.blood.co.uk/giving-blood/who-can-give-blood/)
  3. Body weight > 50kg weight (8 stone 12lbs)
  4. Not known to have any significant past medical history and not having regular follow up (Check Donor Selection Guidelines (http://www.transfusionguidelines.org.uk/)
  5. Willing to provide blood donation and receive autologous blood transfusion
  6. After assessment for eligibility pass all blood donor eligibility criteria
  7. Able to provide informed consent
  8. Should inform overseas travel plan during study period (Check Geographical Disease Risk Index on http://www.transfusionguidelines.org.uk/dsg/gdri) e.g. unable to donate blood for 6 months if travel in a malaria endemic country. Similar guidelines for West Nile virus and T. Cruzi endemic countries.

Exclusion Criteria:

  1. Significant medical, surgical or psychiatric disease that in the opinion of the Clinical Research Fellow would affect subject safety or significantly impact his/her ability to comply with follow-up. This would include any known clotting disorders.
  2. Known allergy or intolerance to Nitrites
  3. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  4. Female subjects must be of non-childbearing potential, defined as follows: postmenopausal females who have had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH>40mIU/ml or females who have had a hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 6 weeks prior to enrolment
  5. Receipt of an investigational drug or biological agent within the 4 weeks prior to study entry or 5 times the drug half-life, whichever is the longer
  6. Predisposed to acute on chronic limb ischemia evident from a history of claudication or known peripheral arterial disease.
  7. No past history of significant adverse events post blood donation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077763


Contacts
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Contact: Nicholas D Gollop, MRCP(UK) 01603 591790 ext 1790 n.gollop@uea.ac.uk

Locations
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United Kingdom
University of East Anglia Recruiting
Norwich, Norfolk, United Kingdom, NR4 7UQ
Contact: Nicholas D Gollop, MRCP    01603 591790 ext 1790    n.gollop@uea.ac.uk   
Sponsors and Collaborators
University of East Anglia
Investigators
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Principal Investigator: Michael P Frenneaux, FRCP, FESC Dean of Medicine, Norwich Medical School, The University of East Anglia, UK

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Responsible Party: University of East Anglia
ClinicalTrials.gov Identifier: NCT03077763     History of Changes
Other Study ID Numbers: 206995
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of East Anglia:
nitrite
haemoglobin
normoxia
hypoxia
vasodilatation
blood
Additional relevant MeSH terms:
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Aneurysm
Dilatation, Pathologic
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical