Clinical Research / studies

The "Clinical Studies" working group deals with the planning, monitoring and evaluation of clinical studies. These include studies from the field of therapy research studies and drug studies of phases I to III. These are mostly efficacy studies that are carried out under ideal conditions. The knowledge gained is used, for example, to improve and expand treatment guidelines. In these studies, primary data is usually collected and evaluated.

The research group of medical biometry supports clinical studies methodically [cooperation ]. This includes:

  • Support on the work on study projects (including Sample Size Calculation and Application)
  • Assistance in preparing the Clinical Trial (including randomization)
  • Performing Interim Analyses
  • Conducting Data Plausibility Checks
  • Conducting Data Analysis
  • Preparing the Final Report
  • Helping to create a Scientific Publication
  • Editing Reviews

These tasks are carried out in close cooperation with the project partners, with whom the necessary funds are raised and with whom we publish together.

If you are interested in a cooperation or have any questions, please contact Anna Suling via the Clinical Studies at IMBE mailbox.

Current Projects

CONQUISTADOR
Title: A Clinical phase I/II, multicenter, Open-label, National study evaluating Quintuplet treatment with ISaTuximab, bortezomib, lenalidomide and dexamethasone plus Etentamig (ABBV-383) (Etenta-Isa-VRd) in primary DiagnOsed high-Risk multiple myeloma patients
Study biometrician: Antonia Zapf
Funding: UKE
Duration of study at IMBE: 01.01.2026 - 31.03.2033

AF-B-STEP
Title: AF-Burden for prognosis and prediction of cardiovacular events
Study biometrician: Antonia Zapf
Funding: EU
Duration of study at IMBE: 01.01.2026 - 31.12.2029

MIA (SFB1713)
Title: SFB on Immune adaptation and activation during pregnancy
Study biometrician: Antonia Zapf
Funding: DFG (SFB)
Duration of study at IMBE: 01.10.2025 - 30.06.2029

VITALITY
Title: The use of intermittent hypoxia-hyperoxia training in cancer survivors with symptoms of fatigue
Study biometrician: Anna Suling
Duration of study at IMBE: 17.07.2025 - 19.05.2027

CARESTAR
Title: High coverage CARotid stenting vs. medical management to prevent EmboliSm from caroTid ARtery lesions
Study biometrician: Antonia Zapf
Funding: Acandis GmbH
Duration of study at IMBE: 19.02.2025 -

GET-FAST
Title: Goettingen/German Endovascular Trial For A Swift Thrombectomy (GET-FAST)
Study biometrician: Antonia Zapf
Funding: DFG
Duration of study at IMBE: 01.01.2025 - 31.12.2028

METARIS-AKI
Title: Meta-analysis based on individual patient data for the identification and stratification of risk factors for the development of functional and structural acute kidney injury phenotypes following cardiac surgery
Study biometrician: Antonia Zapf
Funding: Dr. Werner Jackstädt-Stiftung
Duration of study at IMBE: 01.01.2025 - 31.12.2025

EAST-STROKE
Title: Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE
Study biometrician: Antonia Zapf
Funding: DFG, HORIZON
Duration of study at IMBE: 01.12.2024 - 30.11.2030

CONTOUR
Title: Towards a more standardized bicuspid aortic valve repair: impact of active aortic annulus remodeling on 4D MRI flow patterns and functional outcome of aortic valve repair
Study biometrician: Antonia Zapf
Funding: Else Kröner Fresenius Stiftung
Duration of study at IMBE: 01.10.2024 - 30.09.2028

SCOPE-D
Title: Systematic Care of Patients with Depression in General Practice: A guideline-oriented cluster-randomized intervention using an online self-help program
Study biometrician: Antonia Zapf
Funding: BMBF
Duration of study at IMBE: 15.09.2024 - 30.04.2028

ReSCInD
Title: Reduction of SystemiC Inflammation after ischemic stroke by intravenous DNase administration
Study biometrician: Antonia Zapf
Funding: Else Kröner Fresenius Stiftung
Duration of study at IMBE: 01.09.2024 - 30.09.2026

CONCEPTvsHD7
Title: A secondary analysis of two arms of the HD7 study and one arm of the CONCEPT study to investigate the efficacy of additional treatment with isatuximab
Study biometrician Antonia Zapf
Funding: GMMG
Duration of study at IMBE: 01.08.2024 - 31.05.2026

DETECT II
Title: Continuous finger-cuff arterial pressure monitoring and intraoperative hypotension in non-cardiac surgery patients: the randomized DETECT II trial
Study biometrician: Antonia Zapf
Funding: Edwards Lifesciences
Duration of study at IMBE: 15.04.2024 - 30.06.2026

Fat-dlsCT
Title: The aim of this project is to evaluate new techniques of fat quantification by dual-layer spectral-CT (dlsCT), which were developed in previous projects of the applicant, in clinical studies
Study biometrician: Antonia Zapf
Funding: DFG
Duration of study at IMBE: 12.02.2024 - 31.12.2026

ASPIRE-85
Title: Maintaining intraoperative mean arterial pressure above 85 mmHg to reduce postoperative delirium in older hypertensive patients having non-cardiac surgery: the multicenter randomized ASPIRE-85 trial
Study biometrician: Antonia Zapf
Förderer: BMBF
Duration of study at IMBE: 08.01.2024 - 30.09.2030

Survivorship
Title: The Hamburg "Life After Cancer Programme": Development, implementation and evaluation of a structured survivorship programme – a hybrid effectiveness implementation study
Study biometrician: Antonia Zapf
Funding: Deutsche Krebshilfe
Duration of study at IMBE: 01.01.2024 - 31.12.2027

Magic-HR-ECP
Title: Phase II multicenter study of extracorporal photopheresis with Uvadextm plus standard steroid treatment for high risk acute graft-versus-host disease
Study biometrician: Anna Suling
Funding: Mallinckrodt, Therakos
Duration of study at IMBE: 01.01.2024 - 31.03.2025

PASSION
Title: Thrombolysis with TenectePlase in Acute iSchemic Stroke Patients taking dIrect Oral aNticoagulants – a multicenter randomized placebo-controlled clinical trial
Study biometrician: Anna Suling
Funding: BMBF
Duration of study at IMBE: 12.12.2023 - 30.06.2029

INTENSE
Title: Enhanced postoperative mobilization and bio tracking after colorectal oncological resection
Study biometrician: Antonia Zapf
Funding: Hamburger Krebsgesellschaft
Duration of study at IMBE: 01.10.2023 - 30.09.2025

MethPASmultiE
Title: Methods for planning and evaluating studies with multiple time to event endpoints, taking into account recurring and competing events
Study biometrician: Ann-Kathrin Ozga
Funding: DFG
Duration of study at IMBE: 01.08.2023 - 01.10.2026

Titus
Title: Clinical trial on kidney disease in children
Study biometrician: Antonia Zapf
Funding: Klinik für pädiatrische Nieren-, Leber und Stoffwechselerkrankungen Medizinische Hochschule Hannover
Duration of study at IMBE: 01.08.2023 - 30.06.2025

Radiomics
Title: MRI radiomics-based long-term evaluation and identification of imaging biomarkers for growth prediction of distinct nodular lesions in plexiform neurofibromas in NF1
Study biometrician: Antonia Zapf
Funding: DFG
Duration of study at IMBE: 01.07.2023 - 31.12.2026

BELI(E)VE
Title: Combination treatment of Belantamab Mafodotin and Venetoclax in treatment of relapsed and refractory t(11;14) Multiple Myeloma (Phase I/IIa)
Study biometrician: Antonia Zapf
Funding: Abbvie, GSK
Duration of study at IMBE: 01.02.2023 - 30.04.2032

PELICAN
Title: Effect of personalized hemodynamic management targeting baseline cardiac index on postoperative complications and mortality in high-risk patients having major abdominal surgery: an international multicenter randomized controlled interventional clinical trial
Study biometrician: Antonia Zapf
Funding: Baxter
Duration of study at IMBE: 01.02.2023 - 01.02.2026

TherVacB
Title: Open single center phase 1a trial to assess the safety and immunogenicity of a heterologous protein prime/MVA boost therapeutic hepatitis B vaccine candidate in healthy volunteers
Study biometrician: Antonia Zapf
Funding: Helmholtz
Duration of study at IMBE: 01.01.2023 - 30.09.2026

PRAISE II
Title: Early invasive vs. conservative strategy in acute ischemic stroke patients with non-ST-elevation myocardial infarction
Study biometrician: Antonia Zapf
Funding: DZHK
Duration of study at IMBE: 01.07.2022 -

ProTAC
Title: A multi-center interventional study to assess pharmacokinetics, effectiveness and tolerability of prolonged-release Tacrolimus after Paediatric Kidney Transplantation
Study biometrician: Antonia Zapf
Funding: Chiesi
Duration of study at IMBE: 01.06.2022 - 31.03.2026

PEPPER
Title: Prospective, randomised study on personalised medicine with Pentaglobin following interventional focal treatment in patients with peritonitis
Study biometrician: Antonia Zapf
Funding: UK Aachen, Biotest AG
Duration of study at IMBE: 08.04.2022 - 30.09.2028

UNLOAD_ECMO
Title: Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO (UNLOAD ECMO) - a randomized, controlled, single-centre, clinical trial
Study biometrician: Antonia Zapf
Funding: ABIOMED
Duration of study at IMBE: 01.04.2022 - 30.06.2029

EAST high
Title: Early atrial fibrillation ablation for stroke prevention in patients with high comorbidity burden
Study biometrician: Antonia Zapf
Funding: GCRFF
Duration of study at IMBE: 01.04.2022 - 31.12.2030

MAESTRIA
Title:
Machine Learning and Artificial Intelligence for Early Detection of Stroke and Atrial Fibrillation
Study biometrician: Antonia Zapf
Funding: EU Horizon 2020
Duration of study at IMBE: 01.03.2021 - 31.08.2027

ACTICCA-2
Title: Radiofrequency ablation using transpapillary catheters in patients with cholangiocarcinoma
Study biometrician: Antonia Zapf
Funding: DFG
Duration of study at IMBE: 01.03.2021 - 31.12.2026

CHAP
Title: Congenital Heart Adhesion Prophylaxis (CHAP) Study
Study biometrician: Antonia Zapf
Funding: Industry
Duration of study at IMBE: 01.01.2021 - 31.12.2028

HEDOS
Title: Evaluation of the ISAR-M Thyro detector for diagnosing post-operative bleeding following thyroid surgery. Seamless design combining a Phase III diagnostic study and a Phase IV test-treatment study.
Study biometrician: Antonia Zapf
Funding: Industry
Duration of study at IMBE: 03.09.2020 - 31.08.2026

INCREASE
Title: Interdisciplinary and cross-sectoral care in cardiac surgery, using minimally invasive heart valve procedures as an example
Study biometrician: Antonia Zapf
Funding: Innovationsfonds Neue Versorgungsformen
Duration of study at IMBE: 01.07.2020 - 30.06.2024

STOPPIT
Title: Stop of proton-pump inhibitor treatment in patients with liver cirrhosis - a double-blind, placebo controlled trial
Study biometrician: Antonia Zapf
Funding: BMBF
Duration of study at IMBE: 01.02.2018 - 31.12.2026

ACTICCA
Title: Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma
Study biometrician: Antonia Zapf
Funding: DKH
Duration of study at IMBE: 01.01.2014 - 30.06.2026