Status:
WITHDRAWN
Can we Transfuse Blood Over Shorter Period ?
Lead Sponsor:
King Faisal Specialist Hospital & Research Center
Conditions:
Blood Transfusion Complication
Eligibility:
All Genders
3-14 years
Phase:
PHASE1
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03444610
Start Date
May 31 2018
End Date
March 31 2019
Last Update
April 13 2023
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