Can we Transfuse Blood Over Shorter Period ? (NCT03444610) | Clinical Trial Compass
WithdrawnPhase 1
Can we Transfuse Blood Over Shorter Period ?
Stopped: Phase 1 studies are not performed in Saudi Arabia yet
0Started 2018-05-31
Plain-language 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. 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.
Who can participate
Age range
3 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
can we transfuse blood over shorter period?
Timeframe: 1 year
Trial details
NCT IDNCT03444610
SponsorKing Faisal Specialist Hospital & Research Center