Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03092297
Other study ID # NL59512.058.16
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 16, 2017
Est. completion date December 1, 2022

Study information

Verified date December 2022
Source Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 103
Est. completion date December 1, 2022
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Netherlands Amsterdam Medical Center Amsterdam Amsterdam-Zuidoost, Noord-Holland
Netherlands Leiden University Medical Center Leiden Zuid-Holland

Sponsors (4)

Lead Sponsor Collaborator
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variability of mitoPO2 Variability of mitoPO2 before and after red cell transfusion. This will be compared to traditional parameters used to measure oxygenation and oxygen balance. Variability of mitoPO2 will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study
Secondary Organ damage Value of mitoPO2 measurements for predicting (ischemic) organ damage Value of mitoPO2 in predicting (ischemic) organ damage will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study
Secondary Microcirculation Association of mitoPO2 with the microcirculation Association of the mitoPO2 with the microcirculation will be assessed during 2 predefined moments (before transfusion and 24 hours after transfusion) in the study
Secondary Length of stay Length of hospital-stay and ICu stay Length of stay will be assessed during the 3 months follow-up time
Secondary Mortality 90-day mortality, hospital mortality and ICU mortality Mortality will be assessed during the 3 months follow-up time
Secondary Adverse events Adverse and serious adverse events of the mitoPO2 measurements Association of the mitoPO2 with adverse events will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study
See also
  Status Clinical Trial Phase
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03341338 - Genes-in-Action - Hepcidin Regulation of Iron Supplementation
Completed NCT00060398 - Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer Phase 3
Recruiting NCT05384691 - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions Phase 2
Not yet recruiting NCT06309641 - Methemoglobinemia Following Intravenous Iron Treatment
Completed NCT02912494 - A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02912533 - A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02930850 - Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation N/A
Completed NCT03822884 - Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers Phase 1
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Completed NCT02384122 - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias Phase 3
Completed NCT02603250 - Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda N/A
Completed NCT02176759 - Iron Absorption From Rice Fortified With Ferric Pyrophosphate N/A
Completed NCT02310113 - Transfusion and Skeletal Muscle Tissue Oxygenation N/A
Withdrawn NCT01934842 - A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate N/A
Completed NCT01922479 - Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure Phase 4
Completed NCT01693029 - Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa Phase 3
Terminated NCT01535781 - Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced? N/A
Completed NCT01432717 - Study of ACE-536 in Healthy Postmenopausal Women Phase 1