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Anemia and Red Blood Cells Transfusion in Oncological Surgery (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04101240
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
Oncologic patients experience anemia and anemia is associated with poor prognosis. Transfusion is associated with adverse events, and equipoise remains on the optimal transfusion strategy in oncologic patients in surgical setting. The primary objective of this study is to determine the impact of anemia and red blood cells (RBC) transfusion on post-operative complications and mortality.

Condition or disease
Anemia Surgery Oncology

Detailed Description:
Between 36 and 75% of oncologic patients experience anemia and anemia is associated with poor prognosis. Up to 40% of surgical oncologic patients receive red blood cells (RBC). However, transfusion is associated with adverse events, and equipoise remains on the optimal transfusion strategy in oncologic patients in surgical setting. The primary objective of this study is to determine the impact of anemia and red blood cells (RBC) transfusion on post-operative complications and mortality. This is a retrospective, single center study. All adults admitted to the intensive care unit (ICU) after oncologic surgery within the study period are eligible.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Perioperative Anemia and Red Blood Cells Transfusion on Post-operative Complications After Oncological Surgery
Actual Study Start Date : February 7, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of mortality or any respiratory, cardiac, renal, thromboembolic, infectious and/or hemorrhagic post operative complications [ Time Frame: 30 DAYS (hospital discharge) ]
    mortality or any respiratory, cardiac, renal, thromboembolic, infectious and/or hemorrhagic post operative complications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adults admitted to the intensive care unit (ICU) after oncologic surgery from January 2017 to December 2018 are eligible. The following types of surgery for cancer or metastasis resection with a high risk of bleeding are eligible: thoracic, abdominal, neurosurgery, gynecologic, urologic, otorhinolaryngology or spinal surgery.
Criteria

Inclusion Criteria:

  • Surgery for cancer
  • Admission to intensive care

Exclusion Criteria:

  • no consent

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): NCT04101240


Contacts
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Contact: Cécile AUBRON, PU PH +33298347181 cecile.aubron@chu-brest.fr

Locations
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France
CHRU de Brest, hôpital de la Cavale Blanche Recruiting
Brest, France, 29200
Contact: Cécile AUBRON, PU-PH    +33298347181    cecile.aubron@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Cécile AUBRON, PU PH Service de Médecine Intensive Réanimation

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT04101240    
Other Study ID Numbers: IMPACT (29BRC19.0013)
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
red blood cells transfusion
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases