NCT06493435

Brief Summary

Perioperative anemia is associated with higher risk of red blood cell transfusion, higher rates of morbimortality and lower quality of postoperative recovery. In a context of focussing on higher quality management and improved recovery after surgery, development of Patient Blood management has increased. This study aim to assess PBM protocole in a postoperative context of gynaecological surgery, by comparing indicators at two time periods: 2 and 8 months after establishment of PBM protocol.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Jun 2024

Typical duration for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jun 2024Dec 2026

First Submitted

Initial submission to the registry

June 18, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

June 30, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

July 10, 2024

Status Verified

June 1, 2024

Enrollment Period

1.5 years

First QC Date

June 18, 2024

Last Update Submit

July 4, 2024

Conditions

Keywords

anemiaperioperative periodpost operative recoverypatient blood management

Outcome Measures

Primary Outcomes (1)

  • rate of immediate pre operative anemia

    preoperative Hb\<13g/dL

    at 2 and 8 months after establishment of PBM protocol

Secondary Outcomes (19)

  • rate of preoperative anemia that need to be treated diagnosed during anesthetic consultation

    at 2 and 8 months after establishment of PBM protocol

  • rate of Hemoglobin dosage available during anesthetic evaluation

    at 2 and 8 months after establishment of PBM protocol

  • rate of preoperative iron deficiency that need to be treated diagnosed during anesthetic consultation

    at 2 and 8 months after establishment of PBM protocol

  • adequacy between diagnosed iron deficiency anemia and treatment

    at 2 and 8 months after establishment of PBM protocol

  • effectiveness of iron treatment

    at 2 and 8 months after establishment of PBM protocol

  • +14 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with planned surgery of hyterectomy or cancer related ovariectomy

You may qualify if:

  • age \> 18 years
  • being hospitalised for planned hysterectomy or cancer related ovariectomy

You may not qualify if:

  • less than 18 years
  • non french speaker
  • being under a legal individual protection measure
  • not being able to consent
  • being opposed to data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Sigismond Lasocki

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

June 18, 2024

First Posted

July 10, 2024

Study Start

June 30, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

July 10, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share