Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur (PAAF)
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ClinicalTrials.gov Identifier: NCT03810092 |
Recruitment Status :
Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 23, 2019
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Condition or disease |
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Femoral Fracture |
Study Type : | Observational |
Estimated Enrollment : | 255 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur |
Estimated Study Start Date : | March 2019 |
Estimated Primary Completion Date : | September 2021 |
Estimated Study Completion Date : | September 2021 |

- Hemoglobin rate [ Time Frame: 5 days after surgery ]
- Questionnaire Activities of Daily Living [ Time Frame: Pre-fractural and 6 months after surgery ]
For each question, a point from 0 (worst value) to 1 (best value) is assigned. The total score is 6 points.
A loss of autonomy will be defined by the decrease of one or more points in the ADL.

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Ages Eligible for Study: | 75 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Age ≥ 75 years
- Patient operated on a fracture of the upper extremity of the femur (treatment in the emergency room of the CHD Vendée)
- Patient, family or close relative who does not object to participation in the study
- Patient affiliated to a social security system
- Patient who can be monitored as part of the protocol
Exclusion Criteria:
- Refusal to participate in the study (patient, family or trusted relative)
- Patient with support on the operated limb not authorized by the surgeon
- Patient with an associated fracture (polytrauma, concomitant trauma to the upper limb...)
- Patient deprived of liberty
- Patient not affiliated to a social security system

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): NCT03810092
Contact: Chloé MOREAU | 0251446572 | chloemoreau@chd-vendee.fr |
Principal Investigator: | Romain DECOURS | CHD Vendée |
Responsible Party: | Centre Hospitalier Departemental Vendee |
ClinicalTrials.gov Identifier: | NCT03810092 History of Changes |
Other Study ID Numbers: |
CHD117-17 |
First Posted: | January 18, 2019 Key Record Dates |
Last Update Posted: | January 23, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Fractures, Bone Femoral Fractures Wounds and Injuries Leg Injuries |