BleedingNCT06938789
How Bleeding Affects Delirium in Older Patients With Hip Fractures: The IMPROVE-HIP Study
A study testing Blood Transfusion in people with Bleeding and Hip Fracture, run by University of Aarhus at 2 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Bleeding, Hip Fracture, Delirium - Postoperative
- What is being tested?
- Blood Transfusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 2 sitesDenmark
- Study dates
- 24 Apr 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hip fracture
Who cannot join
- Pathological hip fracture
- Periprosthtic fracture
- Unable to speak or understand Danish
- Does not wish to recieve blood transfusion
- If the investigator finds the patient unable to cooperate to the study (e.g. in case of severe dementia and externalizing behaviour)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Not yet recruiting
Aarhus University Hospital
Aarhus, Central Jutland, 8200
Johanne Bech, MD, +4578431286, jobech@clin.au.dk
- Recruiting
Gødstrup Hospital, Department of internal medicine
Herning, Central Jutland, 7400
Johanne Bech, MD, +4578431286, jobech@clin.au.dk
About this study
Official title: The Impact of Bleeding on Delirium Outcomes in Older Patients With Hip Fractures: A Single-Blind, Randomized Controlled Trial - The IMPROVE-HIP Study
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?
Read more
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.
- Conditions
- Bleeding, Hip Fracture, Delirium - Postoperative
- Being tested
- Blood Transfusion, Standard care
- Keywords
- Hip fracture, Delirium, Blood transfusion
- Medical subject headings
- Hemorrhage, Hip Fractures, Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood TransfusionOther
Blood transfusion is given without delay (within 4 hours) in case of hemoglobin below our threshold.
Standard careOther
These patients recieve our standard care including blood transfusion as usual. Vital parameters and delirium screening are collected three times a day.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Blood Transfusion |
| 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. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Delirium
Occurence of delirium will be evaluted using screening methods three times a day.
Measured: From enrollment to 48 hours after surgery
Secondary outcomes (4)
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.
Measured: Will be evaluated at the 30 day follow-up
Cognitive status
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.
Measured: 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.
Measured: Within 90 days after surgery
90-day mortality
Mortality within the first 90-days after surgery.
Measured: 90 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start24 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Gødstrup Hospital, Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938789
- Sponsor's protocol ID
- JKB-1-2025
- Status last verified
- May 2026
- First submitted
- 14 Apr 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Bleeding on Delirium Outcomes in Older Patients With Hip Fractures: A Single-Blind, Randomized Controlled Trial - The IMPROVE-HIP Study
- ClinicalTrials.gov ID
- NCT06938789
- Acronym / sponsor ID
- JKB-1-2025
- Conditions
- Bleeding, Hip Fracture, Delirium - Postoperative
- Keywords
- Hip fracture, Delirium, Blood transfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Gødstrup Hospital, Aarhus University Hospital
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Transfusion Strategy | Active comparator | Other: Blood TransfusionVital 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 | Other: Standard careThe 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Hip fracture
Key exclusion criteria (5 listed)
- Pathological hip fracture
- Periprosthtic fracture
- Unable to speak or understand Danish
- Does not wish to recieve blood transfusion
- If the investigator finds the patient unable to cooperate to the study (e.g. in case of severe dementia and externalizing behaviour)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood TransfusionBlood transfusion is given without delay (within 4 hours) in case of hemoglobin below our threshold. | Other | Immediate Transfusion Strategy |
| Standard careThese patients recieve our standard care including blood transfusion as usual. Vital parameters and delirium screening are collected three times a day. | Other | Standard Care with Delayed Hemoglobin analysis |
Primary outcome
Number of Participants with Delirium
Time frame: From enrollment to 48 hours after surgery
Occurence of delirium will be evaluted using screening methods three times a day.
4 secondary outcomes
Change from baseline in Quality of Life
Time frame: Will be evaluated at the 30 day follow-up
Cognitive status
Time frame: Will be evaluated at the 30 day follow-up.
Readmission rate
Time frame: Within 90 days after surgery
90-day mortality
Time frame: 90 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Transfusion in people with Bleeding and Hip Fracture, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johanne Bech, MD (+4578431286, jobech@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Delirium (time frame: From enrollment to 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.