Blood Transfusion ComplicationPhase 1NCT03444610
Can we Transfuse Blood Over Shorter Period ?
A Phase 1 study testing Blood transfusion escalation rate in people with Blood Transfusion Complication, run by King Faisal Specialist Hospital & Research Center.
Trial summary
Blood transfusion is very lengthy procedure and consumes a substantial time from patients and health care providers. On average, it may take most if not all the working day which leads to significant constrains on hospital bed utilization. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Blood Transfusion Complication
- What is being tested?
- Blood transfusion escalation rate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2018to 31 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any condition that expected to receive more than one blood transfusion, like thalassemia major or intermedia, sickle cell anemia, aplastic anemia, malignant diseases.
- Age range of 3.0-14 years, inclusive, at the time of study entry.
- Parent or guardian willing and able to provide informed consent.
- Ability to comply with study-related treatments, evaluations, and follow-up.
- Normal Echo study that had been done in the last year.
Who cannot join
- Inability to receive or tolerate chronic red blood cell (RBC) transfusion therapy, due to any of the following:
- Multiple RBC alloantibodies making cross-matching difficult or impossible.
- RBC autoantibodies making cross-matching difficult or impossible.
- Life threatening condition like shock.
- Hemodynamically unstable.
- Hypoxia with oxygen saturation less than 92% on room air.
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- Any patient with signs of respiratory distress (using accessory muscle or acting ala nasi).
- Fluid balance more than 1 liter.
- Known severe allergy (anaphylaxis) to blood transfusion.
- Previous history of Transfusion associated circulatory overload (TACO).
- Heart failure or poor ejection fraction less than 60%.
- Current use of therapeutic agents for heart failure or arrhythmia.
- Newly diagnosed with active cancers in the 1st week of induction therapy.
- Severe anemia- Hb <6gm/dl at the day of transfusion.
- Serum creatinine more than twice the upper limit for age.
About this study
Blood transfusion is very lengthy procedure and consumes a substantial time from patients and health care providers. On average, it may take most if not all the working day which leads to significant constrains on hospital bed utilization. It starts from pre-transfusion testing, clinical assessment, actual administration of blood and post-transfusion care. The main bulk of this procedure is usually related to administration of the blood which typically given over 3 hours (5ml/kg/hour), although there is no strong evidence to support that. Indeed, it has been accepted as standard of care to transfuse blood over short time as in emergency situations.
OBJECTIVE:
Read more
To determine the maximum tolerated blood transfusion rate that can be safely delivered in patient who required blood transfusion i.e. transfusing blood over short time.
METHOD:
This is a phase I, open label, nonrandomized, prospective and rate-finding study. A well-known dose escalation design called 3+3 design will be used to identify the maximum tolerated rate. To assure the safety of such procedure, blood transfusion rate will be escalated very slowly by 1 ml/kg/hour for each cohort until rate-limiting toxicities or maximum of 10ml/kg/hour.
Read the detailed description
Blood transfusion is the mainstay of care for patients with different types of chronic severe anemia like thalassemia major. However, it is associated with serious risks and complications. In addition, blood transfusion is a lengthy procedure starting from pre-transfusion testing, clinical assessment, actual administration of blood and post-transfusion care. The main bulk of this procedure is usually related to administration of the blood which typically given over 3 hours (5ml/kg/hour) or even longer in certain cases. On average, such procedure may take most if not all the working day which leads to significant constrains on hospital bed utilization. Also, it is a significant burden on the patient and his/her family to comply with chronic transfusion program. As consequences, this leads to repeated absences from work or school.
Although, it is the standard of care to infuse blood at rate of 5ml/kg/hour, there is no strong evidence to support that especially in pediatric population. Indeed, it has been accepted as standard of care to transfuse blood over short time in certain cases. For instance, in an emergency situation, it is allowable to infuse blood over less than one hour. Infusion of stem cells is allowed to be given over one hour as well without a major adverse event. In addition, blood donation is usually done over 30 - 60 minutes. As such, the goal for conducting this study is to find out if we can transfuse blood over the short time without causing any harm.
Transfusion associated circulatory overload (TACO) is one of the complications of blood transfusion and known to occur more in adult patients with specific risk factors. TACO is very rare phenomenon in pediatric patients with normal underlying cardiorespiratory functions. In Literature review in pediatrics there was only one case report and that patient had a significant other co-morbidities and risk factors.
In our study, there will be many safety measures taking in our consideration starting by very selective criteria to roll the patients in the study with clear inclusion and exclusion points. Blood transfusion rate determine during the study and will be escalated by 1ml/kg per each cohort only and before starting the blood transfusion vital signs will be taken then 15 minutes after blood transfusion running and by the end of the procedure so there will be 3 times documented vital signs and for more safety issue the patients will be attached to cardiopulmonary monitoring during the whole procedure. Our patients will have ECHO pre-and post-transfusion to detect right ventricle load. Patients will have Brain natriuretic peptide (BNP) level will be done before and after finishing of blood transfusion.
Then at the end, 24 hours post transfusion evaluation will be done for all patients in the study.
- Conditions
- Blood Transfusion Complication
- Being tested
- Blood transfusion escalation rate
- Medical subject headings
- Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusion escalation rateBiological
3+3 dose escalation (3 patients/cohort) each started on a fixed rate (standard is 5 ml/kg/ hr).1st cohort start at 6ml/kg/hr till complete prescribed volume. Rate escalation by 1ml/kg/each cohort until dose limiting toxicities (DLTs) or max of 10ml/kg/hr. If no DLTs new cohort enrolled at the next planned rate. If DLTs seen in 1 patient in the cohort, another 3 patients treated with the same dose level.1ry phase I end point is maximum-tolerated rate (MTR) of blood transfusion that can be infused safely ( max rate at which 1 or fewer of 3 patients experienced DLT) or dose of 10ml/kg/hr. DLT is transfusion related adverse event lead to stop of transfusion. MTR is highest dose at which no more than 1of 6 patients experienced a DLT.15 additional patients enrolled at MTR to confirm safety.
| Study group | Role | What they receive |
|---|---|---|
| Arm (blood transfusion escalation rate) | Other | The intervention for the arm (blood transfusion escalation rate) will be about giving blood transfusion with escalating rate as described in intervention part to Any condition that expected to receive more than one blood transfusion, like thalassemia major or intermedia, sickle cell anemia, aplastic anemia, malignant diseases. Receives: Biological: Blood transfusion escalation rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
can we transfuse blood over shorter period?
primary out come is transfusion associated circulatory overload(TACO), The Frequency will be used in the study to measure the primary outcome (TACO).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start31 May 2018 (estimated)
- Primary completion28 Feb 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
Why it stopped: Phase 1 studies are not performed in Saudi Arabia yet
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Transfusion ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444610
- Sponsor's protocol ID
- IRB 2017-63
- Status last verified
- Apr 2023
- First submitted
- 13 Feb 2018
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Transfuse Blood Over Shorter Period ?
- ClinicalTrials.gov ID
- NCT03444610
- Acronym / sponsor ID
- IRB 2017-63
- Conditions
- Blood Transfusion Complication
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Phase 1 studies are not performed in Saudi Arabia yet
- Enrolment
- 0 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 31 May 2018 (estimated)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Blood transfusion is very lengthy procedure and consumes a substantial time from patients and health care providers. On average, it may take most if not all the working day which leads to significant constrains on hospital bed utilization. It starts from pre-transfusion testing, clinical assessment, actual administration of blood and post-transfusion care. The main bulk of this procedure is usually related to administration of the blood which typically given over 3 hours (5ml/kg/hour), although there is no strong evidence to support that. Indeed, it has been accepted as standard of care to transfuse blood over short time as in emergency situations.
OBJECTIVE:
To determine the maximum tolerated blood transfusion rate that can be safely delivered in patient who required blood transfusion i.e. transfusing blood over short time.
METHOD:
This is a phase I, open label, nonrandomized, prospective and rate-finding study. A well-known dose escalation design called 3+3 design will be used to identify the maximum tolerated rate. To assure the safety of such procedure, blood transfusion rate will be escalated very slowly by 1 ml/kg/hour for each cohort until rate-limiting toxicities or maximum of 10ml/kg/hour.
Detailed description
Blood transfusion is the mainstay of care for patients with different types of chronic severe anemia like thalassemia major. However, it is associated with serious risks and complications. In addition, blood transfusion is a lengthy procedure starting from pre-transfusion testing, clinical assessment, actual administration of blood and post-transfusion care. The main bulk of this procedure is usually related to administration of the blood which typically given over 3 hours (5ml/kg/hour) or even longer in certain cases. On average, such procedure may take most if not all the working day which leads to significant constrains on hospital bed utilization. Also, it is a significant burden on the patient and his/her family to comply with chronic transfusion program. As consequences, this leads to repeated absences from work or school.
Although, it is the standard of care to infuse blood at rate of 5ml/kg/hour, there is no strong evidence to support that especially in pediatric population. Indeed, it has been accepted as standard of care to transfuse blood over short time in certain cases. For instance, in an emergency situation, it is allowable to infuse blood over less than one hour. Infusion of stem cells is allowed to be given over one hour as well without a major adverse event. In addition, blood donation is usually done over 30 - 60 minutes. As such, the goal for conducting this study is to find out if we can transfuse blood over the short time without causing any harm.
Transfusion associated circulatory overload (TACO) is one of the complications of blood transfusion and known to occur more in adult patients with specific risk factors. TACO is very rare phenomenon in pediatric patients with normal underlying cardiorespiratory functions. In Literature review in pediatrics there was only one case report and that patient had a significant other co-morbidities and risk factors.
In our study, there will be many safety measures taking in our consideration starting by very selective criteria to roll the patients in the study with clear inclusion and exclusion points. Blood transfusion rate determine during the study and will be escalated by 1ml/kg per each cohort only and before starting the blood transfusion vital signs will be taken then 15 minutes after blood transfusion running and by the end of the procedure so there will be 3 times documented vital signs and for more safety issue the patients will be attached to cardiopulmonary monitoring during the whole procedure. Our patients will have ECHO pre-and post-transfusion to detect right ventricle load. Patients will have Brain natriuretic peptide (BNP) level will be done before and after finishing of blood transfusion.
Then at the end, 24 hours post transfusion evaluation will be done for all patients in the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm (blood transfusion escalation rate) | Other | Biological: Blood transfusion escalation rateThe intervention for the arm (blood transfusion escalation rate) will be about giving blood transfusion with escalating rate as described in intervention part to Any condition that expected to receive more than one blood transfusion, like thalassemia major or intermedia, sickle cell anemia, aplastic anemia, malignant diseases. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Any condition that expected to receive more than one blood transfusion, like thalassemia major or intermedia, sickle cell anemia, aplastic anemia, malignant diseases.
- Age range of 3.0-14 years, inclusive, at the time of study entry.
- Parent or guardian willing and able to provide informed consent.
- Ability to comply with study-related treatments, evaluations, and follow-up.
- Normal Echo study that had been done in the last year.
Key exclusion criteria (15 listed)
- Inability to receive or tolerate chronic red blood cell (RBC) transfusion therapy, due to any of the following:
- Multiple RBC alloantibodies making cross-matching difficult or impossible.
- RBC autoantibodies making cross-matching difficult or impossible.
- Life threatening condition like shock.
- Hemodynamically unstable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood transfusion escalation rate3+3 dose escalation (3 patients/cohort) each started on a fixed rate (standard is 5 ml/kg/ hr).1st cohort start at 6ml/kg/hr till complete prescribed volume. Rate escalation by 1ml/kg/each cohort until dose limiting toxicities (DLTs) or max of 10ml/kg/hr. If no DLTs new cohort enrolled at the next planned rate. If DLTs seen in 1 patient in the cohort, another 3 patients treated with the same dose level.1ry phase I end point is maximum-tolerated rate (MTR) of blood transfusion that can be infused safely ( max rate at which 1 or fewer of 3 patients experienced DLT) or dose of 10ml/kg/hr. DLT is transfusion related adverse event lead to stop of transfusion. MTR is highest dose at which no more than 1of 6 patients experienced a DLT.15 additional patients enrolled at MTR to confirm safety. | Biological | Arm (blood transfusion escalation rate) |
Primary outcome
can we transfuse blood over shorter period?
Time frame: 1 year
primary out come is transfusion associated circulatory overload(TACO), The Frequency will be used in the study to measure the primary outcome (TACO).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Blood transfusion escalation rate in people with Blood Transfusion Complication, run by King Faisal Specialist Hospital & Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
can we transfuse blood over shorter period? (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.