Trial Outcomes & Findings for 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 (NCT NCT03810092)

NCT ID: NCT03810092

Last Updated: 2025-09-19

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 255 participants
• Primary outcome timeframe: 5 days after surgery
• Results posted on: 2025-09-19

Participant Flow

Participant milestones

Measure	Intent to Treat Population Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur
Overall Study STARTED	255
Overall Study COMPLETED	195
Overall Study NOT COMPLETED	60

Reasons for withdrawal

Measure	Intent to Treat Population Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur
Overall Study no ground support	17
Overall Study ADL not done at J0	16
Overall Study No hemoglobin measure at J5	27

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intent to Treat Population n=238 Participants Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur
Age, Continuous	88 years n=238 Participants
Sex: Female, Male Female	181 Participants n=238 Participants
Sex: Female, Male Male	57 Participants n=238 Participants
BMI	23 kg/m² n=235 Participants • Missing value
Anterior fracture	81 Participants n=238 Participants
Hospitalisation time	6 days n=238 Participants

PRIMARY outcome

Timeframe: 5 days after surgery

Outcome measures

Measure	Intent to Treat Population n=159 Participants Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur
Hemoglobin Rate	10 g/dl Interval 9.2 to 10.9

PRIMARY outcome

Timeframe: 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.

Result showed here is the difference of ADL score intra patient

Outcome measures

Measure	Intent to Treat Population n=181 Participants Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur
Questionnaire Activities of Daily Living	1 score on a scale Interval 0.5 to 2.0

Adverse Events

Intent to Treat Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 37 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Romain DECOURS

CHD VENDEE

Phone: 02 51 44 65 72

Email: romain.decours@ght85.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place