IRONCARE: Iron Treatment in Older Patients With Hip Fractures
IRONCARE: Iron Treatment in Older Patients With Hip Fractures - A Double-blinded Placebo-controlled Randomized Trial
The aim of this study is to investigate the effects of intravenous (IV) iron therapy compared to alternate-day oral iron treatment and no supplementation in older patients with hip fractures. This study will examine the impact of iron treatment on fatigue, functional decline, fear of falling, cognitive impairment, and quality of life, as well as its effects on iron stores and hemoglobin levels, with the overall goal of improving postoperative rehabilitation.
The trial will be conducted on five different hospitals in the Central Region of Denmark (Region Midtjylland).
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Ole Vincent Ancker, MD
- 전화번호: +4551322385
- 이메일: ole.ancker@rm.dk
연구 연락처 백업
- 이름: Merete Gregersen, ph.d.
- 이메일: meregreg@rm.dk
연구 장소
-
-
-
Aarhus N, 덴마크, 8200
- Aarhus Univeristy Hospital
-
연락하다:
- Ole Vincent Ancker, MD
- 전화번호: +4551352385
- 이메일: ole.ancker@rm.dk
-
Herning, 덴마크, 7400
- Regional Hospital Gødstrup
-
연락하다:
- Ole Vincent Ancker, MD
- 전화번호: +4551352385
- 이메일: ole.ancker@rm.dk
-
Horsens, 덴마크, 8700
- Regional Hospital Horsens
-
연락하다:
- Ole Vincent Ancker, MD
- 전화번호: +4551352385
- 이메일: ole.ancker@rm.dk
-
Randers, 덴마크, 8930
- Regional Hospital Randers
-
연락하다:
- Ole Vincent Ancker, MD
- 전화번호: +4551352385
- 이메일: ole.ancker@rm.dk
-
Viborg, 덴마크, 8800
- Regional Hospital Viborg
-
연락하다:
- Ole Vincent Ancker, MD
- 전화번호: +4551352385
- 이메일: ole.ancker@rm.dk
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Hip fracture (ICD-10 codes: DS720, DS721 and DS722)
- Low energy trauma
- Age ≥ 75 years
- Hemoglobin ≤7.0 mmol/L (11 g/dL) during hospital admission
Exclusion Criteria:
- Pathological fracture
- Periprosthetic fracture
- Inability to understand or speak Danish
- Dysphagia and thus inability to swallow study medication
- Signs of iron overload, hemochromatosis, or hemosiderosis
- Liver disease (cirrhosis or hepatitis) and transaminase levels >3 times upper limit of normal
- Known allergy to iron formulations
- Severe asthma
- Severe hypophosphatemia: <0.35 mmol/L
- Patients already receiving iron supplementation that cannot be paused for the study period
- Cognitive impairment that results in either memantine-treatment or a Short Portable Mental Status Questionnaire (SPMSQ) score > 4
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: IV Iron
Intravenous iron once and placebo tablets on alternate days for 90 days
|
Intravenous Ferric Derisomaltose shortly after surgery and placebo tablets on alternate days for 90 days
Placebo tablets on alternate days for 90 days
|
|
활성 비교기: Oral Iron
Intravenous sodium chloride once and ferro sulfate tablets on alternate days for 90 days
|
Oral iron sulfate on alternate days for 90 days and IV placebo once shortly after surgery
100 ml Sodium Chloride (NaCl)
|
|
위약 비교기: Placebo
Intravenous sodium chloride once and placebo tablets on alternate days for 90 days
|
Placebo tablets on alternate days for 90 days
100 ml Sodium Chloride (NaCl)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fatigue
기간: Baseline and days 30 and 90 after discharge
|
Measured by Multidimensional Fatigue Inventory tool (MFI-20).
MFI-20 is a questionnaire of 20 questions answered on a 5-point scale from "yes, that is true" (1 point) to "no, that is not true" (5 points).
A higher score indicates greater severity of fatigue.
|
Baseline and days 30 and 90 after discharge
|
|
Hemoglobin increment
기간: Baseline and days 30 and 90 after discharge
|
Defined as a change of level of a minimum of 1.24 mmol/L (2 g/dL).
The level of hemoglobin will be measured with a venous blood sample
|
Baseline and days 30 and 90 after discharge
|
|
Safety profile
기간: Days 15, 30, 45 and 90 after discharge
|
Measured as the prevalence and severity of adverse events associated with iron treatment
|
Days 15, 30, 45 and 90 after discharge
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Physical function - NMS
기간: Baseline and days 30 and 90 after discharge
|
New Mobility score (NMS) is used to assess the participant's mobility. The participant will be asked three questions ranging from "no difficult and no walking aid" (3 points) to "not able to at all" (0 points). The score ranges from 0 - 9 points. A higher score indicates a higher level of independent mobility. |
Baseline and days 30 and 90 after discharge
|
|
Physical function - handgrip strength
기간: Baseline and days 30 and 90 after discharge.
|
Handgrip strength is measured by using a dynamometer that measures the pressure made from a hand grip on the dynamometer in kilograms.
A higher score indicates higher handgrip strength.
|
Baseline and days 30 and 90 after discharge.
|
|
Physical function - 30 second sit-to-stand-test
기간: Baseline and days 30 and 90 after discharge.
|
30 second sit-to-stand-test is used as a parameter for strength, muscle power and dynamic balance. The test is performed by placing a chair with the back against a wall. The participant must be seated on the chair with their arms crossed and are then encouraged to fully stand and sit as many times as possible in 30 seconds. If the arms are used to stand, the score will be 0. A low score indicates low physical ability, and a higher score indicates high physical ability. |
Baseline and days 30 and 90 after discharge.
|
|
Fear of Falling
기간: Days 30 and 90 after discharge
|
Measured by Short Fall Efficiency Scale-International which is a 7 questions questionnaire assessing the fear of falling from 7 points (low concern of falling) to 28 points (high concern of falling).
|
Days 30 and 90 after discharge
|
|
Quality of life
기간: Baseline and 90 days after discharge
|
European Quality of Life - 5 Dimensions (EQ-5D-5L) which is a standardized questionnaire used to evaluate health-related quality of life.
There are 5 questions ranging from level 1 - 5 Level 1 indicates: no problems Level 2 indicates: slight problems Level 3 indicates: moderate problems Level 4 indicates: severe problems Level 5 indicates: extreme problems And lastly a visual analogue scale from 0 - 100 where 100 means the best health imaginable and 0 means the worst health imaginable.
|
Baseline and 90 days after discharge
|
|
Cognitive impairment
기간: Baseline and days 30 and 90 after discharge
|
Measured by Brief Assessment of Impaired Cognition (BASIC). The tool consists of three questions to the patient (0-6 points), word finding (0-5 points), categorized recalling of photos (0-8 points) and lastly three questions to a next of kin (0-6 points). A low score indicates impaired cognition. In cases where no next of kins is available the conversion table is used of an estimated score according to the guidance from the Danish Dementia Research Centre. |
Baseline and days 30 and 90 after discharge
|
|
Biochemical iron status - transferrin
기간: Baseline and on days 30 and 90 after discharge
|
p-transferrin (μmol/L) measured by a venous blood sample.
|
Baseline and on days 30 and 90 after discharge
|
|
Biochemical iron status - ferritin
기간: Baseline and on days 30 and 90 after discharge
|
p-ferritin (μg/L) measured by a venous blood sample
|
Baseline and on days 30 and 90 after discharge
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRONCARE-2026
- 2026-526949-94-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .