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

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
Morten Sorensen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01116479
First received: April 28, 2010
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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
Cancer
Anaemia
Other: Blood transfusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116479

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

No publications provided

Responsible Party: Morten Sorensen, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01116479     History of Changes
Other Study ID Numbers: H-1-2009-109
Study First Received: April 28, 2010
Last Updated: November 3, 2014
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Anaemia, transfusion, cancer, chemotherapy, Quality of life

ClinicalTrials.gov processed this record on November 19, 2014