Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03092297
Previous Study | Return to List | Next Study

Insufficient Cellular Oxygen in ICU Patients With Anaemia (INOX ICU-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03092297
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
Leiden University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Erasmus Medical Center
Information provided by (Responsible Party):
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research

Brief Summary:
The purpose of this study is whether the mitochondrial oxygenation tension (mitoPO2) is a feasible and reliable tool in ICU patients with anaemia undergoing red cell transfusion to ultimately personalize blood transfusion decisions in the ICU.

Condition or disease
Critical Care Anemia Erythrocyte Transfusion Oxygen Mitochondria

Detailed Description:

Evidence is increasing that in some cases a Hb trigger of 7-8g/dl may be too low and te question arises whether an individualized red cell transfusion strategy may benefit critically ill patients. New studies have shown the potential of protoporphyrin IX-triple state lifetime technique to measure mitochondrial oxygenation tension (mitoPO2) in vivo, which possibly is an early indicator of oxygen disturbance in the cell and therefore a physiological trigger for red cell transfusion. The goals are: 1. Determining the feasibility of using mitoPO2 and the variability of mitoPO2 measurements in critically ill intensive care unit (ICU) patients before and after receiving a red cell transfusion 2. Describing the effects of red cell transfusion and the associated change in [Hb] on mitoPO2 and on other physiologic measures of tissue oxygenation and oxygen balance 3. Describing the association between mitoPO2 and vital organ functions. Included patients will undergo red cell transfusion as planned. However, red cell transfusion will be delayed by 2 hours. At multiple predefined moments data collection including blood samples and measurements of mitoPO2 will take place.

The results of this study cannot be immediately translated to clinical practice. Using these results, the investigators will design a phase 2 diagnostic study, most probably a randomized clinical trial that will yield applied knowledge with respect to personalizing red cell transfusion. Application will be in ICU patients with anaemia who might or might not profit from red cell transfusions. It will lead to a reduction of both over- and under- transfusion.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Insufficient Cellular Oxygen in ICU Patients With Anaemia: the INOX ICU-2 Study
Actual Study Start Date : May 16, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
ICU patients with anaemia
At admission to the ICU all patients, or their legal representatives, expected to stay at the ICU for longer than 24 hours will be asked to participate in the study and will be asked informed consent. ICU patients with anaemia in whom a central venous catheter is already in place and in whom a red cell transfusion is planned, will be included in the study.



Primary Outcome Measures :
  1. Variability of mitoPO2 [ Time Frame: Variability of mitoPO2 will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study ]
    Variability of mitoPO2 before and after red cell transfusion. This will be compared to traditional parameters used to measure oxygenation and oxygen balance.


Secondary Outcome Measures :
  1. Organ damage [ Time Frame: Value of mitoPO2 in predicting (ischemic) organ damage will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study ]
    Value of mitoPO2 measurements for predicting (ischemic) organ damage

  2. Microcirculation [ Time Frame: Association of the mitoPO2 with the microcirculation will be assessed during 2 predefined moments (before transfusion and 24 hours after transfusion) in the study ]
    Association of mitoPO2 with the microcirculation

  3. Length of stay [ Time Frame: Length of stay will be assessed during the 3 months follow-up time ]
    Length of hospital-stay and ICu stay

  4. Mortality [ Time Frame: Mortality will be assessed during the 3 months follow-up time ]
    90-day mortality, hospital mortality and ICU mortality

  5. Adverse events [ Time Frame: Association of the mitoPO2 with adverse events will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study ]
    Adverse and serious adverse events of the mitoPO2 measurements


Biospecimen Retention:   Samples Without DNA
Blood samples will be taken for measurement of: troponin, creatinine kinase, creatinine, hemoglobin, lactate, central venous oxygen saturation, arterial saturation, arterial oxygen tension, and venous oxygen tension. Remaining plasma will be frozen and stored for further evaulation


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients admitted to the intensive care unit with a Hb below 6.3 mmol/l, with a central venous catheter in situ, who are planned to undergo a transfusion of red blood cells
Criteria

Inclusion Criteria:

  • adult patient admitted to the ICU
  • Hb below 6.3 mmol/l (10 g/dl)
  • central venous catheter in situ
  • red cell transfusion planned

Exclusion Criteria:

  • adults without a legal representative to ask for informed consent
  • patients less than 18 years old
  • pregnant or breast feeding women
  • patients in need of emergency red cell transfusion e.g. bleeding
  • not having a central venous catheter in situ
  • porphyria and or known photodermatosis
  • patients with an expected ICU stay <24 hours
  • patients with hypersensitivity to the active substance or to the plaster material of ALA

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): NCT03092297


Contacts
Layout table for location contacts
Contact: Meryem Baysan, MD +31715297274 M.Baysan@lumc.nl
Contact: Johanna G van der Bom, PhD, MD +310715268871 J.G.van_der_Bom@lumc.nl

Locations
Layout table for location information
Netherlands
Amsterdam Medical Center Recruiting
Amsterdam, Amsterdam-Zuidoost, Noord-Holland, Netherlands, 1105 AZ
Contact: N P Juffermans, PhD, MD       n.p.juffermans@amc.uva.nl   
Principal Investigator: N P Juffermans, PhD, MD         
Leiden University Medical Center Recruiting
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Contact: M S Arbous, PhD, MD    ++31715261678    M.S.Arbous@lumc.nl   
Contact: J G van der Bom, PhD, MD    +31715268871    J.G.van_der_Bom@lumc.nl   
Principal Investigator: M Baysan, MD         
Erasmus University Medical Center Not yet recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015 CE
Contact: B Mik, PhD, MD       e.mik@erasmusmc.nl   
Principal Investigator: B Mik, PhD, MD         
Sponsors and Collaborators
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Leiden University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Erasmus Medical Center
Investigators
Layout table for investigator information
Study Chair: Johanna G van der Bom, PhD, MD Leiden University Medical Center and Sanquin Research Leiden
Study Chair: M S Arbous, PhD, MD Leiden University Medical Center
Principal Investigator: M Baysan, MD Leiden University Medical Center and Sanquin Research Leiden
  Study Documents (Full-Text)

Documents provided by Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research:
Study Protocol  [PDF] February 27, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
ClinicalTrials.gov Identifier: NCT03092297    
Other Study ID Numbers: NL59512.058.16
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: to be decided
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia
Hematologic Diseases