Trial · NCT03528564
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Vanguard Phase (Initial 12 patients): Feasibility of using Erythropoietin + Intravenous Iron to Treat Preoperative Iron Restrictive Anemia | 18 weeks from randomization | The primary outcome of the vanguard phase is to determine the feasibility of using erythropoietin + intravenous iron to treat preoperative iron restrictive anemia. Feasibility will be measured according to subject enrollment rates, with adherence to the treatment schedule of \>80%. |
| Primary | Full Study: Preoperative Hemoglobin Concentration | 6 weeks from randomization | The primary outcome of the full study is preoperative hemoglobin concentration, as measured on the day of surgery in patients with iron restricted anemia. |
| Secondary | Post-Treatment Hemoglobin Concentration | 12 weeks from randomization | Change in post-treatment hemoglobin concentration from baseline |
| Secondary | Change in Hemoglobin Concentration from Initiation of Treatment | 6 weeks from randomization | Rate of hemoglobin change from initiation of treatment to final preoperative hemoglobin |
| Secondary | Postoperative Hemoglobin Concentration | 0 weeks from surgery and 12 weeks from surgery | Hemoglobin concentration on postoperative day 2 (prior to hospital discharge); and 4-6 weeks after surgery |
| Secondary | Red Blood Cell Transfusions | 6 weeks from surgery | Rate of RBC transfusion and number of units transfused during surgery and up to 6 weeks postoperatively |
| Secondary | Deep Vein Thrombosis | 12 weeks from surgery | Incidence of DVT up to 12 weeks postoperatively |
| Secondary | Composite of Morbidity | 3 months from surgery | Incidence of a composite clinical outcome including death, stroke, myocardial infarction, pulmonary embolism, infection, acute kidney injury, and deep vein thrombosis from treatment to up to 3 months post surgery |
| Secondary | Surgical Wound Infection | 6 weeks from surgery | Incidence of superficial and deep wound infection from treatment to 4-6 weeks post surgery |
| Secondary | Assessment of Iron Status | 6 weeks from surgery | Hematological outcomes for treatment efficacy including: Hb, ferritin, hepcidin, and transferrin saturation (TSAT) pre-operatively and 4-6 weeks postoperatively |
| Secondary | Digit Span Test | 6 weeks from surgery | Cognitive assessment of memory span |
| Secondary | California Verbal Learning Test | 6 weeks from surgery | Cognitive assessment of word learning, recall and recognition, as well as episodic memory |
| Secondary | Neuropsychological Impairment Scale | 6 weeks from surgery | A subjective cognitive assessment of cognitive functioning. This is a 95-item questionnaire, with all items rated on a scale from 0 (not at all) to 5 (extremely). From the 95 total items, 80 items describe neurophysiological symptoms (Global measure of impairment; GMI), 10 items describe affective disturbance, and 5 items assess test-taking attitudes. A total GMI score can range from 0-320, with higher scores indicating an increased impairment index. |
| Secondary | Trail Making Test | 6 weeks from surgery | Cognitive assessment of processing speed |
| Secondary | Digit Symbol | 6 weeks from surgery | Cognitive assessment of response speed, sustained attention, and visual spatial skills |
| Secondary | Montreal Cognitive Assessment | 6 weeks from surgery | Cognitive assessment of global cognitive functioning |
| Secondary | Stroop Colour and Word Test | 6 weeks from surgery | Cognitive assessment of processing speed |
| Secondary | Wisconsin Card Sorting Test | 6 weeks from surgery | Cognitive assessment of a participant's ability to set-shift (display flexibility in the face of changing conditions) |
| Secondary | Hospital Anxiety and Depression Scale | 6 weeks from surgery | Cognitive assessment of anxiety and depression levels. A total score between 0-7 indicates normal levels of depression or anxiety; a total score between 8-10 indicates borderline abnormal levels of anxiety or depression; and a total score between 11-21 indicates abnormal levels of depression or anxiety |
| Secondary | Cost Analysis | 12 weeks from randomization | Assessment of relative cost of treatment and cost savings associated with transfusion avoidance will be assessed (see projected cost analysis; appended) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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