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| Name | Class |
|---|---|
| Gødstrup Hospital | OTHER |
| Aarhus University Hospital | OTHER |
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The goal of this clinical trial is to investigate whether early detection of bleeding and prompt blood transfusions can help prevent delirium in patients aged 75 and older who are admitted to the hospital with hip fractures. The main question the trial aims to answer is:
Do patients aged 75 and older with hip fractures benefit from earlier treatment of anemia (low blood count) to reduce the risk of delirium?
Researchers will compare early diagnosis and treatment of bleeding with standard care to determine if it helps lower the risk of developing delirium.
Participants will:
Undergo blood tests, have their vital signs monitored, and be screened for delirium three times a day for the first 48 hours after surgery.
Receive blood transfusions promptly if their hemoglobin levels fall below a specified threshold.
Attend a follow-up visit at 30 days to assess cognitive function and overall quality of life.
Attend another follow-up at 90 days to evaluate hospital readmissions and survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Transfusion Strategy | Active Comparator | Vital parameters, delirium screening, and blood samples are collected three times a day. If the hemoglobin level falls below the predefined threshold, red blood cell transfusion is administered without delay (within 4 hours). |
|
| Standard Care with Delayed Hemoglobin analysis | Placebo Comparator | The patients recieve standard care. To maintain patient blinding vital parameters, delirium screening, and blood samples are collected three times a day, just as in the intervention arm, however, hemoglobin analysis is delayed to avoid influencing transfusion decisions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Transfusion | Other | Blood transfusion is given without delay (within 4 hours) in case of hemoglobin below our threshold. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Delirium | Occurence of delirium will be evaluted using screening methods three times a day. | From enrollment to 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Quality of Life | The overall Quality of life will be assed by the Overall Quality of life Depression List (OQoL-DL). It will be used to asses patients in both groups at the 30 day follow-up. | Will be evaluated at the 30 day follow-up |
| Cognitive status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johanne Bech, MD | Contact | +4578431286 | jobech@clin.au.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Not yet recruiting | Aarhus | Central Jutland | 8200 | Denmark |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D006620 | Hip Fractures |
| D000071257 | Emergence Delirium |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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| Standard care | Other | These patients recieve our standard care including blood transfusion as usual. Vital parameters and delirium screening are collected three times a day. |
|
Short Portable Mental Status Questionnaire (SPMSQ). Sum score 0-10, higher scores indicates cognitive impariment. The SPMSQ will be used to assess cognitve status in patients in both groups at follow-up. |
| Will be evaluated at the 30 day follow-up. |
| Readmission rate | Readmission within 90 days after surgery. Readmission is defined as any uplanned, acute rehospitalisation in this period. | Within 90 days after surgery |
| 90-day mortality | Mortality within the first 90-days after surgery. | 90 days after surgery. |
| Gødstrup Hospital, Department of internal medicine | Recruiting | Herning | Central Jutland | 7400 | Denmark |
|
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006298 |
| Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |