NCT04101240

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

September 23, 2019

Last Update Submit

September 23, 2019

Conditions

AnemiaSurgeryOncology

Keywords

red blood cells transfusion

Outcome Measures

Primary Outcomes (1)

  • Number of mortality or any respiratory, cardiac, renal, thromboembolic, infectious and/or hemorrhagic post operative complications

    mortality or any respiratory, cardiac, renal, thromboembolic, infectious and/or hemorrhagic post operative complications

    30 DAYS (hospital discharge)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Surgery for cancer
  • Admission to intensive care

You may not qualify if:

  • no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest, hôpital de la Cavale Blanche

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

AnemiaNeoplasms

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Cécile AUBRON, PU PH

    Service de Médecine Intensive Réanimation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile AUBRON, PU PH

CONTACT

+33298347181cecile.aubron@chu-brest.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 24, 2019

Study Start

February 7, 2019

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

September 24, 2019

Record last verified: 2019-09

Locations

FR(1)