## Protocol Section
### Identification Module
**NCT ID:** NCT01116479

**Acronym:** HaemOPtimal

**Brief Title:** Optimal Transfusion in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)

**Official Title:** Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)

#### Organization Study ID Info
**ID:** H-1-2009-109
#### Organization
**Class:** OTHER
**Full Name:** Rigshospitalet, Denmark
### Status Module
#### Completion Date
**Date:** 2013-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-11-05

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-11-03

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2013-12

**Type:** ACTUAL

#### Start Date
**Date:** 2010-03

**Status Verified Date:** 2014-11

#### Study First Post Date
**Date:** 2010-05-05
**Type:** ESTIMATED
**Study First Submit Date:** 2010-04-28
**Study First Submit QC Date:** 2010-05-04
**Why Stopped:** low accrual
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Rigshospitalet, Denmark

#### Responsible Party

**Investigator Affiliation:** Rigshospitalet, Denmark

**Investigator Full Name:** Morten Sorensen

**Investigator Title:** MD, PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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

**Detailed Description:** Title:

Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated with Chemotherapy (HaemOPtimal)

Background:

Cancer patients treated with chemotherapy very often become anaemic, which have profound negative impact of their quality of life. Blood transfusions can ameliorate symptoms caused by anaemia. Data are lagging with regard to what threshold should be used when offering blood transfusion.

Aim:

The primary aim is to determine which end-points reflect symptoms caused by anaemia in cancer patients treated with chemotherapy. The secondary aims are to collect data to estimate sample size in a future definitive study and to compare symptom relief using to different transfusion thresholds.

End-points:

* Numeric Rating Scale measuring fatigue, dizziness, palpitations, headache, and dyspnea.
* FACT-G,
* FACT-An (Total anemia scale) including a fatigue subscale
* Patient-assessed WHO performance status

Design:

Open two-arm interventional randomised feasibility study

Intervention:

* Blood transfusion.
* Randomisation 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.

Population:

Cancer patients treated with chemotherapy

Inclusion criteria:

* Documented cancer
* Planned treatment with chemotherapy
* Age 18 years or older
* 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.

Number of patients:

Transfusion of at least 30 patients in each intervention arm. An estimated number of 90 patients will be randomised in each arm (180 in total) as a third of included patients are expected to require transfusion.

### Conditions Module

**Conditions:**

- Cancer

- Anaemia

**Keywords:**

- Anaemia, transfusion, cancer, chemotherapy, Quality of life

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 180

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Blood transfusion

**Label:** Haemoglobin (<6.0 mmol/l)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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

**Intervention Names:**

- Other: Blood transfusion

**Label:** Haemoglobin (< normal range)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Haemoglobin (< normal range)

- Haemoglobin (<6.0 mmol/l)

**Description:** Blood transfusion with packed erythrocytes

**Name:** Blood transfusion

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** 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

#### Secondary Outcomes

**Description:** Frequency of complications to blood transfusion (need for termination of transfusion due to complications, chills, fever, hives, drop in blood pressure, dyspnea, other)

**Measure:** Safety and transfusion complications

**Time Frame:** during or after transfusion

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Copenhagen

**Country:** Denmark

**Facility:** Blood bank, Righospitalet

**Zip:** DK-2100

**Location 2:**

**City:** Copenhagen

**Country:** Denmark

**Facility:** Dept. of Oncology, Rigshospitalet

**Zip:** DK-2100

#### Overall Officials

**Official 1:**

**Affiliation:** Dept. of Oncology, Righospitalet, Denmark

**Name:** Morten Sorensen, MD, Phd

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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 Section

### Condition Browse Module - Ancestors

- ID: D000006402

- Term: Hematologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M4070

- Name: Anemia

- Relevance: HIGH

- As Found: Anemia

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000740

- Term: Anemia

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M207501

- Name: Chrysarobin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
