Can we Transfuse Blood Over Shorter Period ?

Sponsored by King Faisal Specialist Hospital & Research Center

About this trial

Last updated 3 years ago

Study ID

IRB 2017-63

Status

Withdrawn

Type

Interventional

Phase

Phase 1

Placebo

Accepting

3 to 14 Years

All Sexes

Trial Timing

Ended 7 years ago

What is this trial about?

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.

What are the participation requirements?

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.