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

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ClinicalTrials.gov Identifier: NCT01116479
Recruitment Status : Terminated (low accrual)
First Posted : May 5, 2010
Last Update Posted : November 5, 2014
Sponsor:
Information provided by (Responsible Party):
Morten Sorensen, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Cancer Anaemia Other: Blood transfusion Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)
Study Start Date : March 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Morten Sorensen, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01116479     History of Changes
Other Study ID Numbers: H-1-2009-109
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014

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