Can we Transfuse Blood Over Shorter Period ?

NCT03444610 | Withdrawn Phase 1

• 1 other identifier: IRB 2017-63
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Blood Transfusion Complication

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year

Study Arms (1)

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.

Biological: Blood transfusion escalation rate

Interventions

Blood transfusion escalation rate BIOLOGICAL

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.

Arm (blood transfusion escalation rate)

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

MeSH Terms

Conditions

Transfusion Reaction

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 23, 2018
• Study Start: May 31, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 31, 2019
• Last Updated: April 13, 2023

Record last verified: 2023-04