An interventional study of INTERCEPT and Standard of Care in Anemia, sponsored by Swiss Transfusion SRC. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-13.
Sponsored by Swiss Transfusion SRC · Not applicable, Interventional, and Treatment
The pathogen reduction (PR) system for Whole Blood (WB) using Amustaline (S-303) and Glutathione (GSH) has a potential to decrease transfusion-transmitted infection. There is scientific basis to hypothesize, that cells containing DNA and RNA such as bacteria, viruses and parasites that could be present in blood collected from asymptomatic infected donors are inactivated in the treated whole blood and therefore reduce the risk of transfusion-transmitted infections. The aim of the study is to gather data to support the safety of whole blood products that underwent treatment with amustaline and glutathione and data to support a larger sufficiently powered efficacy study. This study will evaluate the safety of the system for whole blood in adult patients with anemia.
This study is designed as a randomized, controlled, open-label study. The aim is to explore the safety of the whole blood product treated with a PR system using amustaline and glutathione.
The study will enroll 20 patients with anemia. 20 patients will be randomized either to treated WB (Test) or Standard of Care, either Red Blood Cells or Whole Blood (Control).
Screening:
All potentially eligible patients at the participating institution will be approached for study consent prior to study transfusion. Enrolled patients will be asked for consent to the storage of their samples for a future project in TTI Project. Illiterate patients can be consented by an impartial witness.
Patients who consent to the study will be assigned a study ID number and undergo screening.
Screening data collection and procedures will include: Demographics (age, sex), vital signs, height, weight, indication for anticipated transfusion, medical history including history of bleeding and transfusion and concomitant medications. A physical examination, including skin inspection, will be performed. Blood samples will be drawn for a hematological panel (including complete blood count, blood chemistry, blood type, coagulation (aPTT, PT and/or INR) and pregnancy test (if applicable). Immunohematology tests will be performed in a patient's sample at the blood transfusion center. This includes the Direct Antibody Test (DAT), immune reactivity to RBCs that have been processed with the INTERCEPT Blood System (IBS RBC), red cell alloantibody screen (Indirect Antibody Test (IAT) / Indirect Coombs).
Blood samples (pre/post-treatment) for future research on transfusion-transmitted infections will be archived in a biobank of the Institut Pasteur de Côte d'Ivoire (IPCI)
Randomization:
After successful screening, eligible patients will be assigned to a treatment arm by randomization. Randomization will be performed in the blood center by sequentially selecting a randomization envelope starting with the lowest number (e.g., 1 for the first eligible subject in ascending order up to envelope number 20 for the 20th subject).
The ratio of patients assigned to the Test and Control group will be 1:1. Each subject will receive a Test product or SOC. The assigned blood product number must be noted on the randomization assignment envelope and on the release form. The product number will also be entered into the case report form (CRF).
The replacement strategy in this Phase I clinical trial is based on the aim to reach twenty evaluable patients ("evaluable patients" is defined as those patients who are randomized and receive any study transfusion).
If a randomized subject withdraws or is withdrawn from the study prior to the administration of any study transfusion, or does not receive any study transfusion through 7-days post-randomization, this subject will be replaced by the next eligible subject using the same randomization envelope. If a randomized subject receives a conventional (untreated) blood transfusion prior to study transfusion, the patient will be replaced as described above.
All patients who received at least one study product will be included into the analysis of evaluable patients and followed up to the final study visit on Day 58.
All used and unused randomization envelopes will be kept in the Site File for reconciliation.
Pre-transfusion visit:
Vital signs, height, weight, hemoglobin will be assessed and urine dipstick test for detection of blood will be performed. If the patient consented to future research on TTI, a sample is drawn.
Treatment:
Patients will be transfused with one investigational product or SOC on Day 1. In case he or she requires further transfusion support to treat anemia, enrolled patients may be treated with a second study transfusion. A patient who requires a second blood component will receive a second treatment with a study product from the assigned treatment arm. This patient will be included into the analysis of evaluable patients and followed up to Day 58, the end of study visit.
Post-transfusion visit(s):
Patients will be hospitalized for 24 hours after each study transfusion to allow close monitoring and data collection uniquely for the study purpose since their condition would allow an outpatient treatment. 3 hours and 6 hours after initiating each study transfusion vital signs, skin inspection, and urine dipstick will be performed.
24-hours post-transfusion vital signs, concomitant medication/intervention will be assessed, laboratory samples for hemoglobin, coagulation assays (aPTT, PT and/or INR) and potassium and a sample for determination of residual S-300 will be taken.
If a subject consented to future research on TTI, a second blood sample (post-transfusion) will be taken and archived in the biobank.
In case clinical symptoms of transfusion-related bacterial contamination occur, a blood sample will be taken during the post-transfusion period and sent for microbiological analysis. Those patients will be treated according to local SOC.
Safety Follow-up visit Day 28 (+/-3 days after last study transfusion):
At day 28 (+/-3 days) a physical examination, vitals and blood samples will be collected for laboratory analysis of safety variables (e.g., complete blood count, coagulation, blood chemistry) and urine dipstick.
All Adverse Events (AE), Transfusion Reactions (TR) and unanticipated adverse device effects will be reviewed and recorded for the period from the first study transfusion through day 28 after the last study transfusion.
The Investigators will assess each AE/TR for relation to the study transfusion. Available clinical diagnostic tools will be used to classify occurring transfusion reactions by the definitions of Swissmedic grading scale.
Final study visit Day 58 (+/-7 days after last study transfusion) At the final study visit, the immune reactivity of patient serum to RBCs treated with amustaline/GSH and a DAT test will be performed.
SAEs will be reviewed and recorded for the period of 58 days up to the final study visit.
The Investigators will assess each Serious Adverse Event (SAE) for relation to the study transfusion. Depending on the availability of clinical diagnostic tools, the transfusion reactions will be classified by the definitions of Swissmedic grading scale.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
Browse Anemia studies →Swiss Transfusion SRC is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Stable anemic patients according to local clinical guidelines qualified to receive a whole blood transfusion in a non-emergency situation.
Inclusion criteria:
Patients must fulfill all of the following inclusion criteria:
Female patients of must:
Exclusion criteria:
The presence of any one of the following exclusion criteria will lead to exclusion:
Stable anemic patients according to local clinical guidelines qualified to receive a transfusion in a non-emergency situation.
Inclusion criteria:
Patients must fulfill all of the following inclusion criteria:
Female patients of childbearing potential must:
Exclusion criteria:
The presence of any one of the following exclusion criteria will lead to exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Whole blood treated with amustaline and glutathione, a pathogen reduction technology (PRT), ordered and administered to study patients by their treating physicians
Device: INTERCEPT
Standard of Care (either red blood cells or whole blood)
Device: Standard of Care
The pathogen reduction process begins with a unit of whole blood collected according to local standards and procedures at the blood center. The blood unit is treated with amustaline and glutathione (INTERCEPT blood system for whole blood) according to manufacturer's instructions. The INTERCEPT blood system is performed on a single unit of not leuco-reduced whole blood treated with amustaline and glutathione in CPD
Also known as: Experimental
The control article is Standard of Care, either RBC or whole blood collected by the Centre National de Transfusion Sanguine (CNTS), processed according to the local procedure and in compliance with quality criteria defined by the manufacture regarding the volume, hemoglobin content, hematocrit, storage temperature, age of blood and storage in the predefined anticoagulant solution.
Also known as: Control
Severe Transfusion Reactions
The primary safety outcome will be assessed by the occurrence of transfusion reactions \>= grade 2 according to the Swissmedic transfusion reaction grading and causality criteria (Appendix 1), during the first 24 hours following administration of each study transfusion, with probable, possible or certain causality to the transfused product
Time frame: 24 hours
Adverse events
All adverse events including all transfusion reactions within 28 (+/-3) days and all SAEs within 58 (+/- 7) days after last study transfusion.
Time frame: 58 (+/-7)
Treatment-emergent antibodies
Treatment-induced antibodies to amustaline/GSH treated RBCs within 58 (+/-7) days after last study transfusion
Time frame: 58 (+/-7)
Treatment-emergent auto-antibodies
Treatment emergent auto-antibody within 58 (+/-7) days after study transfusion
Time frame: 58 (+/-7)
Hemoglobin increment
The hemoglobin increment 24h post transfusion will be calculated as the difference between the hemoglobin value most proximate before the transfusion and approximately 24h post transfusion, adjusted by hemoglobin content transfused.
Time frame: 24 hours
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2019; primary completion for Mar 2020, 9 months later.
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This study is withdrawn, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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