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Can we Transfuse Blood Over Shorter Period ?

NCT03444610 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-04-13

No results posted yet for this study

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

Interventions

BIOLOGICAL

Blood transfusion escalation rate

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.

Sponsors & Collaborators

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2019-02-28
Completion
2019-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03444610 on ClinicalTrials.gov