Transfusion of red cells in hematopoietic stem cell transplantation (TRIST): study protocol for a randomized controlled trial

Table 3 Schedule and Evaluation of Outcomes

		Study Entry	Scheduled Assessments (± 3 days as inpatient; ± 5 days as outpatient)
			Day 0	Day 7	Day 14	Day 28	Day 60	Day 100
Demographics/Baseline characteristics	Trial Case Number	x
	Date of Birth	x
	Gender	x
	Indication for HSCT	x
	Stem cell Source	x
	CD34 cell count	x
	Donor Type (allos only)	x
	HLA compatibility (allos only)	x
	ABO blood type	x
	ABO compatibility (allos only)	x
	CMV compatibility (allos only)	x
	Karnofsky Functional Scale	x
	Conditioning regimen	x
	HCT-CI	x
	CBC	x	all available values
Quality of Life Scales	EQ-5D and FACT-BMT†	x		x	x	x	x	x
Transfusion Assessments	Red Cells Transfusion Assessment		As needed
	Platelets Transfusion Assessment		As needed
	Plasma and Cryoprecipitate Transfusion Assessment		As needed
Transplant Assessments	Bleeding Assessment				x	x		x
	Infection Assessment				x	x		x
	VOD Assessment^#					x
	Bearman Toxicity Assessment^					x
	aGVHD*							x
	Admission to ICU		As needed
	Hospital Admission		As needed
	Mortality Assessment							x

NB Scheduled Assessments will be required even if the patient is discharged; the assumption is that no transplant toxicities have occurred if the patient is discharged
† Quality of Life Scales may be completed at home to be mailed or handed in
^# Presence/Absence within the 1st 21 days of HSCT (by Seattle Criteria) ^ Highest grade to be completed * Highest grade of aGVHD to be completed
HLA: Human Leukocyte Antigen; CMV: Cytomegalovirus; HCT-CI: Hematopoietic Cell Transplantation-Comorbidity Index; CBC: Complete Blood Count;
VOD: Veno-occlusive Disease; aGVHD: acute graft versus host disease; ICU: Intensive Care Unit

ISSN: 1745-6215