Trial record 4 of 239 for:    Open Studies | blood transfusion

Red Cell Transfusion Goals in Patients With Acute Leukemias

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02086773
First received: March 4, 2014
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

The purpose of this study to determine if a lower hemoglobin transfusion threshold, 7 g/dL, has a safety profile similar to that of the current standard transfusion threshold of 8 g/dL.


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Acute Lymphocytic Leukemia (ALL)
Acute Myelogenous Leukemia (AML)
Acute Promyelocytic Leukemia (APL)
Procedure: Restrictive Transfusion threshold
Procedure: Standard transfusion threshold
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Prospective Randomized Clinical Feasibility Study of Red Cell Transfusion Goals in Patients With Acute Leukemias

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • The safety of a restrictive transfusion threshold of 7g/dL compared to subjects with the current standard transfusion threshold of 8g/dL [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
    The difference in the primary composite safety endpoint between the two arms of the study will be reported with a 90% credible interval


Secondary Outcome Measures:
  • The feasibility of doing a large randomized trial comparing these transfusion strategies [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    The feasibility of a large randomized non-inferiority clinical trial will be assessed using the composite endpoint defined for this study as well as an endpoint of mortality alone.

  • The number of red cells and platelets transfused per patient [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • The number of patients with neutropenic infections [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • The number of Grade 3 and 4 bleedings [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • The length of inpatient stay [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Treatment related mortality [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • End organ dysfunction [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • Number of patients with Eastern Cooperative Oncology Group (ECOG) performance status <2 [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • The incidence of treatment cross-over due to symptomatic anemia [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Cost savings of the transfusion with a reduced transfusion threshold [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: April 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Restrictive transfusion threshold
Patients receive blood transfusion with transfusion threshold of 7g/dL Hb
Procedure: Restrictive Transfusion threshold
RBC transfusion with transfusion threshold of 7g/dL Hb.
Active Comparator: Standard transfusion threshold
Patients receive blood transfusion with transfusion threshold of 8g/dL Hb
Procedure: Standard transfusion threshold
RBC transfusion with transfusion threshold of 8g/dL Hb

Detailed Description:

Transfusion of red blood cells (RBCs) is vitally important for the care of patients undergoing myelosuppressive therapy for acute leukemia. The therapeutic approach to this disease involves the use of high doses of chemotherapy to treat the blood cancers and bone marrow disorders; but it damages the marrow and blood system. Malignant and healthy stem cells are affected by the chemotherapy, and even when the malignant cells are killed, it can take weeks for the healthy cells to reconstitute the marrow. At diagnosis and before bone marrow recovery post treatment, RBCs are needed to support the patient. Current practices at major comprehensive cancer centers all utilize liberal hemoglobin transfusions triggers of 8-9 g/dL or higher. Higher hemoglobin levels in these high risk patients may have benefits such as better energy and organ function. However, research in a variety of clinical settings, suggests that a higher hemoglobin transfusion threshold is associated with the same or even higher mortality rates compared to lower hemoglobin thresholds (7-8 g/dL). These other settings include prospective randomized trials in high-risk orthopedic surgery patients, critically ill adult and pediatric ICU patients, acute GI bleed patients, and patients undergoing cardiac surgery. One clinical scenario where the ideal transfusion threshold is unknown is in patients receiving chemotherapy for hematologic malignancies. Transfusion requirements and triggers have not been systematically studied in acute leukemia or other cancers. Acute leukemia carries a high mortality; any unnecessary increase in morbidity or mortality is not acceptable. Without a clear benefit of higher transfusion thresholds, the added risks and costs of transfusion may be substantial and unnecessary. The investigators plan to study this issue in this pilot and feasibility study by randomly assigning patients treated for acute leukemia to be transfused with RBCs at either a higher or lower hemoglobin concentration trigger point. In this way, the investigators will be able to accurately determine if there is benefit or harms to having a lower or higher red cell count during the induction treatment and recovery period for patients with acute leukemias. This study will also collect information evaluating the advantages and disadvantages of the two transfusion thresholds and the feasibility of expanding the study to a large randomized trial.This safety data will serve as a platform for a larger mortality study in leukemia and possibly additional studies in solid tumors.

  Eligibility

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

Inclusion Criteria:

  • Acute leukemia patients (AML, ALL, APL, high grade MDS)
  • Admitted with plans for inpatient myelosuppressive chemotherapy (with standard of care or protocol regimens)

Exclusion Criteria:

  • Age less than 18 years
  • Acute coronary syndrome as defined by active chest pain, dynamic ECG changes, troponin greater than 2.5
  • Active blood loss
  • Receiving erythropoietin stimulating agents prior to admission
  • Chronic Renal Failure in Renal Replacement Therapy
  • Documented wish against transfusion for personal or religious beliefs
  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: NCT02086773

Contacts
Contact: Amy DeZern, MD, MHS 410-502-7208 adezern1@jhmi.edu
Contact: Karen King, MD 410-614-0205 kking@jhmi.edu

Locations
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Amy DeZern, MD, MHS    410-502-7208    adezern1@jhmi.edu   
Principal Investigator: Amy DeZern, MD MHS         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Amy DeZern, MD, MHS The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02086773     History of Changes
Other Study ID Numbers: J13126, NA_00089706
Study First Received: March 4, 2014
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Acute Leukemia
Red Cell Transfusion

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Promyelocytic, Acute
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014