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

This study has been terminated.
(low accrual)
Information provided by (Responsible Party):
Morten Sorensen, Rigshospitalet, Denmark Identifier:
First received: April 28, 2010
Last updated: November 3, 2014
Last verified: November 2014
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

Condition Intervention Phase
Other: Blood transfusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)

Resource links provided by NLM:

Further study details as provided by Morten Sorensen, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status [ Time Frame: Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion ]
    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

Secondary Outcome Measures:
  • Safety and transfusion complications [ Time Frame: during or after transfusion ]
    Frequency of complications to blood transfusion (need for termination of transfusion due to complications, chills, fever, hives, drop in blood pressure, dyspnea, other)

Estimated Enrollment: 180
Study Start Date: March 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Haemoglobin (<6.0 mmol/l)
Blood transfusion thresholds:Haemoglobin < 6.0 mmol/l (9.9 g/dL)
Other: Blood transfusion
Blood transfusion with packed erythrocytes
Experimental: Haemoglobin (< normal range)
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
Blood transfusion with packed erythrocytes

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01116479

Blood bank, Righospitalet
Copenhagen, Denmark, DK-2100
Dept. of Oncology, Rigshospitalet
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Principal Investigator: Morten Sorensen, MD, Phd Dept. of Oncology, Righospitalet, Denmark
  More Information

Responsible Party: Morten Sorensen, MD, PhD, Rigshospitalet, Denmark Identifier: NCT01116479     History of Changes
Other Study ID Numbers: H-1-2009-109
Study First Received: April 28, 2010
Last Updated: November 3, 2014

Keywords provided by Morten Sorensen, Rigshospitalet, Denmark:
Anaemia, transfusion, cancer, chemotherapy, Quality of life processed this record on May 25, 2017