Optimal Transfusion in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)

NCT01116479 | Terminated Phase 2

• 1 other identifier: H-1-2009-109
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

This an open two-arm interventional randomised feasibility study in anaemic patients treated with chemotherapy. Randomisation is performed between two transfusion thresholds: Haemoglobin \< 6.0 mmol/l (9.9 g/dL) versus haemoglobin \< 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l (13.4 g/dL) for males.Primary end-point is quality of life

Conditions

Cancer; Anaemia

Keywords

Anaemia, transfusion, cancer, chemotherapy, Quality of life

Outcome Measures

Primary Outcomes (1)

• FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status

  Patient assessed FACT-G (Functional Assessment of Therapy in General), FACT-An (Functional Assessment of Therapy in Anaemia), Numeric Rating Scale on symptoms of anaemia (fatigue, dizziness, dyspnea, palpitations, headache) and performance status before each cycle of chemotherapy, before transfusion and daily in seven days after transfusion

  Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion

Secondary Outcomes (1)

• Safety and transfusion complications

  during or after transfusion

Study Arms (2)

Haemoglobin (<6.0 mmol/l)

ACTIVE COMPARATOR

Blood transfusion thresholds:Haemoglobin \< 6.0 mmol/l (9.9 g/dL)

Other: Blood transfusion

Haemoglobin (< normal range)

EXPERIMENTAL

Blood transfusion threshold: Haemoglobin \< 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l (13.4 g/dL) for males

Other: Blood transfusion

Interventions

Blood transfusion OTHER

Blood transfusion with packed erythrocytes

Haemoglobin (< normal range); Haemoglobin (<6.0 mmol/l)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented cancer
• Planned treatment with chemotherapy
• Age older than 18 years
• Informed consent

You may not qualify if:

• Heart failure (NYHA 3 and 4)
• Prior serious complications to blood transfusion
• Medical conditions that require special considerations for blood transfusion
• Treatment with erythropoiesis-stimulating agents

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (2)

Blood bank, Righospitalet

Copenhagen, DK-2100, Denmark

Location

Dept. of Oncology, Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Related Publications (2)

• Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

  PMID: 41114449 DERIVED

• Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

  PMID: 34932836 DERIVED

MeSH Terms

Conditions

Neoplasms; Anemia

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Morten Sorensen, MD, Phd

  Dept. of Oncology, Righospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: May 5, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 5, 2014

Record last verified: 2014-11

Locations

DK (2)