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Clinical trials and research units

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Learning and research

Clinical trials and research units

Waikato has the goal of becoming an internationally recognised centre for research. It has a number of active clinical trials and research units based on the Waikato Hospital campus including critical care research, respiratory and gastroenterology research, cardiology trials, trauma research, neurology research, breast cancer (Waikato Breast Cancer Research Trust), rheumatology research and trials, cancer and blood research and trials, diabetes research, renal trials, and researching the use of digital health.

Current studies

  • ARROW trial for recurrent wheeze/asthma in preschool children
  • PRECARE trial – for preschool children with mild asthma/recurrent wheeze

Main areas of research

  • Recurrent wheeze/Asthma in childhood
  • Bronchiolitis
  • Medical conditions in child health

Contact

Julia Laing
Waikids research nurse coordinator
Email: waikidsresearch@waikatodhb.health.nz

 

 

Research and Clinical Trials
Local and national level audit projects conducted for review of peri-operative outcomes for patients undergoing surgery.

Small, single centre investigator-led clinical trials as well as multi-centre investigator led RCT’s are conducted through collaborative groups such as the Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA-CTN) and Public Health Research Institute in Canada (PHRI).

The research department also maintains academic ties with Auckland University and Oxford University and Columbia University with various collaborative projects.

Areas of interest include EEG during anaesthesia, regional blockade and cardiac anaesthesia. Collaborative projects with Cardiac surgery research and Critical care research groups are also a focus.

Anaesthesia and analgesia effects on brain slices are studied with the aid of Dr Logan Voss (Waikato and Auckland Universities)

Molecular 3D computational modelling are studied with the aid of Dr Amir Irani (Waikato Hospital)

 Current Studies

Anaesthesia

  • The Sevoflurane Trial: Topical Sevoflurane in Chronic Painful Ulcers
  • Topical Sevoflurane to painful, non-healing wounds in palliative care
  • Subcut administered pharmacokinetics of dexmedetomidine in healthy adult volunteers

Cardiac Anaesthesia

  • CLIP NZ:II- Frozen vs fresh platelets for the management of post-op surgical bleeding following cardiac surgery

Anaesthetic EEG

  • Delta-Max Trial: Customised delta-wave targeting during anaesthesia as a measure of depth of anaesthesia during surgery

ANZCA Trials

  • Poise-3 Trial: Peri-operative ischaemic evaluation Trial
  • TRIG’s Trial: TXA to reduce Infection after GI Surgery

Audits

  • The department also collects audit data for a variety of projects.

Research Team

Professor Jamie Sleigh

Dr Kelly Byrne

Dr Amy Gaskell

Dr Nicola Whittle

Dr Timothy Starkie

Dr Kate Goldstone

Dr Logan Voss (Scientist)

Dr Amir Irani (Bio-molecular Simulation)

Dr Antara Banerji (PhD Student)

Jonathan Termaat- Research and clinical trial Co-ordinator

Email: Jonathan.termaat@waikatodhb.health.nz

 

There are multiple different subtypes of breast cancer and the Breast Cancer Research team coordinate clinical trials introducing new surgical and radiotherapy techniques; and drug treatments for different types of breast cancer. We also research to introduce devices, reduce side effects and improve quality of life.

Clinical trials

The Breast Cancer Research Unit enables phase 2 - 4 clinical trials investigating new treatments or care to breast cancer across different disciplines e.g. breast surgery, plastic surgery, radiology, medical or radiation oncology. We coordinate clinical trials for prevention; treatment of ductal carcinoma insitu; and treatment and care in early and metastatic breast cancer. The purpose of our clinical trials and studies is to improve outcomes, improve quality of life, and reduce side effects.

For further information about trials in recruitment, follow-up or closed, please go to: https://www.breastcancerresearch.org.nz/current-clinical-trials/

Breast Cancer Foundation National Register - Midlands Region

The Breast Cancer Foundation National Register - Midland Region is coordinated from our Breast Cancer Research unit.

This is a Ministry of Health secured web-based database built with the intention of creating a population based picture of breast cancer care in New Zealand.

The register records detailed information about diagnosis, treatment and outcomes of patients with breast cancer, which allows the medical community to monitor standards of care in the Waikato and benchmark against national and international treatment standards.

This confidential database also allows multidisciplinary research into the many aspects of the breast cancer position in the Waikato, Midland Health region, and New Zealand.

For further information on audit work and projects or observational studies from Register data, please go to: https://www.breastcancerresearch.org.nz/breast-cancer-foundation-national-register/

Contacts

Jenni Scarlet
Research Nurse/Clinical Trial Coordinator
Phone: 07 8398726 Extension: 97916

Cathy Head
Data Manager Breast Cancer Foundation National Register - Midland Region
Phone: 07 8398726 Extension: 97503

Hina Pokaia
Research Nurse/Clinical Trial Coordinator
Phone: 07 8398726 Extension: 97960

To enable investigator led unfunded or underfunded clinical trials and research and audit, a group of dedicated breast cancer specialist doctors and nurses set up the Breast Cancer Research Trust in 2000. This Trust has enabled us to submit grant applications and fundraise to make research and audit happen!

To find out more about Breast Cancer Research Trust please visit: www.breastcancerresearch.org.nz

Main areas of research

  • Medical Oncology Phase Ib-III: Areas of interest are melanoma, advanced solid tumours, non-small cell lung cancer, renal cell carcinoma, urothelial cancer, oestrogen receptor positive breast cancer, head and neck cancers, prostate, colorectal, ovarian and pancreatic.  Currently recruiting to 2 x renal cell trials
  • Radiation Oncology: currently recruiting for bladder cancer.
  • Haematology, malignant and non-malignant: Areas of interest are acute myeloid leukaemia (AML), multiple myeloma, Non-Hodgkin Lymphoma (NHL), Chronic lymphocytic leukemia (CLL), Lymphoma, Myelodysplastic syndromes (MDS) and Acute lymphoblastic leukemia (ALL).  Will be recruiting to CLL Naïve trial from Q3 2024 and  NHL trial from Q1 2025.
  • We also support in-house, investigator-lead trials.

Our goal is to have clinical trials available in the main tumour streams across the unit. We continue to seek good quality trials that offer our patients an opportunity to participate in novel treatment options.  This allows us access to treatment for anticancer and non-malignant drugs that are non-funded, giving our patients a greater range of treatment options.

Contact

CBRTU Startup
CBRTU-Startup@waikatodhb.health.nz

Trials completed or closed to recruitment

  • Medical Oncology: melanoma, prostate cancer, advanced solid tumours, breast cancer, gastric cancer, colorectal cancer, pancreatic cancer, non-Hodgkins lymphoma, non-small cell lung cancer, endometrial cancer, ovarian cancer.
  • Haematology: PNH, chronic myeloid leukaemia (CML), chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), multiple myeloma, Hodgkins lymphoma, haemophilia, myelofibrosis.
  • Radiation Oncology: glioblastoma multiforme (GBM), endometrial cancer, prostate cancer, rectal cancer, head and neck cancer, breast cancer, bladder cancer, lymphoma.

Main areas of research

  • Heart attacks.
  • Heart failure.
  • Heart valve disease.
  • Heart rhythm disorders.
  • Continuing evaluation of current treatments (Data Collection Registries).

Our Cardiology Department has been involved in clinical research for almost 50 years. Cardiology patients in Waikato Hospital participated in more than 140 international multi-centre trials, which have led to the evidence-based treatments that are used today.

Contact
Liz Low

Phone: 07 839 7136

Main areas of research
The Cardiothoracic research team has the ambitious mission to conduct world-leading innovative translational research to improve the care of patients in New Zealand with cardiopulmonary disease.

The team plans to conduct research that improves care and outcomes for patients; reduces risk and complexity for surgeons; is needs responsive and tackles under-represented areas, such as aortic disease and rheumatic heart disease.

They are keen to work with different research departments within Waikato Hospital and beyond such as industry and universitiesto build collaborative partnerships on projects.

Current research areas of interest:

  • Aortic Disease
  • Rheumatic disease

Completed research:

  • Humidified CO2 Study: Effect of insufflation techniques on de-airing during valve surgery.
  • RespirAq Study:  Humidifier usability during invasive ventilation

Audits
The department also collects audit data for a variety of projects, including:

  • Prosthetic heart valve choice and anticoagulation in patients with rheumatic heart disease: A qualitative study
  • Surgical Aortic Valve Replacement (SAVR) at Waikato Hospital
  • Follow-up of new-onset atrial fibrillation following isolated aortic valve replacement with/without coronary bypass graft
  • Trends of Surgical Ablation for AF in Aotearoa NZ
  • Investigation of the durability and safety of bioprosthetic and mechanical valves in patients with rheumatic valve disease.
  • Functional coronary artery stenosis impact on coronary artery bypass flow and resistance intraoperatively

Collaborative projects

  • CALIPSO: Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study CLIPNZ-II: cryopreserved versus liquid platelets
  • LAAOS III Trial: occlusion versus non-occlusion of LAA and stroke
  • QRK309 Trial: QPI-1002 Phase 3 for prevention of MAKE in subjects at high risk for AKI.

Recent Publications (2022-2024)

  • Al-Azri, K., Goldstone, K., Phillips, J., Bhana, J., Patel, N., & Warkentin, T. E. (2023). Severe autoimmune heparin-induced thrombocytopenia postcardiac surgery: Implications for subsequent cardiac surgery. American journal of hematology, 98(12), 1953–1958. https://doi.org/10.1002/ajh.27123
  • Barton, C., Ganesh, J., Sharma, V., & Lin, Z. (2023). Protocol-based removal of intra-aortic balloon pump using bioabsorbable anchor/collagen-based vascular closure device following cardiac surgery. JTCVS techniques, 20, 92–95. https://doi.org/10.1016/j.xjtc.2023.04.012
  • Byrne, K., Wotherspoon, S., & Patel, N. N. (2022). No-Touch Harvest: The Solution to Laboring in Vein?. Journal of cardiothoracic and vascular anesthesia, 36(5), 1231–1233. https://doi.org/10.1053/j.jvca.2021.11.029
  • El-Gamel A. (2022). Proximal Aortic Graft Infection: Time for Treatment in an Aortic Centre?. Heart, lung & circulation, 31(1), 4–6. https://doi.org/10.1016/j.hlc.2021.11.001
  • El-Gamel, A., & Chan, B. (2022). Left Atrial Appendage Closure: Novel Cor-Knot Lasso Technique Ensures Complete and Safe Ligation. The Annals of thoracic surgery, S0003-4975(22)00202-8. Advance online publication. https://doi.org/10.1016/j.athoracsur.2022.01.046
  • Gimpel, D., Pan, A., Manikavasagar, V., Lao, C., Brown, L., McCormack, D. J., Lin, Z., Meikle, F., Conaglen, P., Stephenson, D., Lawrenson, R., & El-Gamel, A. (2022). Early diagnosis of surgically curable lung cancer is commonly serendipitous. The New Zealand medical journal, 135(1556), 44–52.
  • Kang, M., Sharma, V. J., Omundsen, M., McCormack, D., & Kejriwal, N. (2022). Challenges of emergency thoracotomy in a regional New Zealand setting. Emergency medicine Australasia : EMA, 10.1111/1742-6723.14029. Advance online publication. https://doi.org/10.1111/1742-6723.14029
  • Karcher, C., Jurisevic, C., Southwood, T., McCormack, D., Rogers, A., Levine, A., & Dunning, J. (2023). The Australasian ANZSCTS/ANZICS guidelines on cardiothoracic advanced life support (CALS-ANZ). Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine, 24(3), 218–223. https://doi.org/10.51893/2022.3.SA3
  • Lloyd, J., Gilliat, N., Porter, G., & Pirone, F. (2023). A case report of an ischaemic stroke, caused by a primary cardiac intimal sarcoma. BMC cardiovascular disorders, 23(1), 59. https://doi.org/10.1186/s12872-023-03090-5
  • Prakash, M., Sharma, V., Oh, T., Lo, C., Parkinson, G., McCormack, D., Conaglen, P., Lin, Z., Kejriwal, N., Meikle, F., Peplow, E., Bhana, J., & El Gamel, A. (2022). Evaluation of the effects of three designs of oxygenators with integrated filters on clinical and haematological outcomes at an Australasian cardiothoracic unit. Perfusion, 2676591221090751. Advance online publication. https://doi.org/10.1177/02676591221090751
  • J Sharma, V., Bhana, J., Lolohea, S., & Meikle, F. (2022). How to do hyperthermic intrathoracic chemotherapy for thoracic pseudomyxoma peritonei. ANZ journal of surgery, 92(4), 868–869. https://doi.org/10.1111/ans.17134
  • Sharma, V. J., Kang, M., Ganesh, J. S., McCormack, D. J., Prakash, M., Moore, R., Patel, N. N., & El-Gamel, A. (2022). Can We Better Differentiate Type A Dissections: Evaluating the Role of Aortic Ratios. Heart, lung & circulation, S1443-9506(22)00143-3. Advance online publication. https://doi.org/10.1016/j.hlc.2022.03.011
  • Stevens, N., Patel, S., & Kejriwal, N. (2023). How I do it: repair of sternal fracture with bone graft and plating. ANZ journal of surgery, 93(10), 2502–2504. https://doi.org/10.1111/ans.18549
  • Thanalingam, Y., Krim, A. O. A., & Kejriwal, N. (2022). Bilateral costal cartilage fractures sustained in the gym during repeated bench press exercises. Trauma case reports, 42, 100720. https://doi.org/10.1016/j.tcr.2022.100720
  • Waqanivavalagi S. W. (2023). Low and intermediate risk aortic dissection detection risk score and negative D-dimer: a word of caution. The New Zealand medical journal, 136(1582), 87–90.
  • Waqanivavalagi S. W. F. R. (2024). Temporary pacing following cardiac surgery - a reference guide for surgical teams. Journal of cardiothoracic surgery, 19(1), 115. https://doi.org/10.1186/s13019-024-02619-9

Prizes
2024 Best Registrar Presentation Prize, Annual Cardiothoracic Meeting of Aotearoa New Zealand awarded to Dr Francis Cheung

Grants

  • 2023 Foundation100 Fellowship from the Heart Foundation awarded to Dr Nishith Patel
  • 2023 Summer Studentships – Shownok Saha
  • 2023 Grant (ongoing) - CALIPSO Study with Dr Kelly Byrne
  • 2022 Grant (ongoing) - CLIPNZII Study with Dr Kelly Byrne
  • 2022 Summer Studentships – Yattheesh Thanalingham and Aditya Arora
  • 2021 Grant - AUT Ventures Ltd
  • 2018 Grant - Fisher & Paykel Healthcare Ltd

Contacts

Dr Nishith Patel
Research Lead, Cardiothoracic Surgery

Kelly Henderson
Research Coordinator, Cardiothoracic Surgery

All enquiries: Kelly.henderson@waikatodhb.health.nz

 

Main areas of research
Critical care

Contacts
Fiona Gray
Jenny Karp
Santosh Sharma
Mark Tan

Active/recruiting research

  • REMAP- CAP- Randomised Embedded Multifactorial Adaptive Platform Trial of Community-Acquired Pneumonia.

  • MEGA-ROX - The Mega Randomised Registry Trial Comparing Conservative vs. Liberal Oxygen Targets

  • EPO-Trauma - ErythroPOietin alfa to prevent mortality and reduce severe disability in critically ill TRAUMA patients: a multi-centre, stratified, double-blind, randomised, placebo-controlled trial. (The EPO-TRAUMA trial)

Completed research

  • PEPTIC study – Proton pump inhibitors versus histamine receptor blockers for ulcer prophylaxis therapy in the ICU.
  • TARGET study – The augmented versus routine approach to giving energy trial.
  • TRANSFUSE study – A multi-centre randomised double blinded phase III trial of fresh versus standard issue of red blood cells for transfusion.
  • PLUS study – A pivotal, multicentre, parallel-group, double blind randomised controlled trial of plasmalyte use versus saline in adult critically ill patients deemed to require fluid resuscitation
  • Continuous vs Intermittent β-Lactam Antibiotic Infusions in Critically Ill Patients With Sepsis - The BLING III Randomized Clinical Trial
  • FAB study – Fluid after Bypass study.
  • Gallus NIV Mask Trial – with Fisher and Paykel
  • BALANCE – Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness – A prospective multicentre, randomised, non-inferiority, concealed allocation trial of shorter duration (7 days) versus longer duration (14 days) antibiotic treatment for critically ill patients with bloodstream infections.
  • The NAC-ICU trial - Nebulised Acetylcysteine vs Nebulised Saline in invasively ventilated ICU patients with significant secretions burden 

Main areas of research
Diabetes – cardiovascular disease, kidney disease, hypertension, diabetic retinopathy, neuropathy, glucose control, devices for glucose monitoring and insulin delivery, diabetes and driving.

Contact
Annie Johnstone
Study coordinator
Phone: 021 240 9087
Annie.Johnstone@waikatodhb.health.nz 

Active/recruiting research

Diabetes and kidney disease - two studies.

Completed studies

Diabetes and cardiovascular outcomes.

Main areas of research
High quality data to provide a picture of trauma in our community, using the Midland Trauma Registry and clinical trials involving trauma patients.

Contact
Grant Christey
Trauma Director

Phone: 021 761 941
www.midlandtrauma.nz

Active/recruiting research
Patients for the PATCH (Pre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage) clinical trial.

Completed research
Research using registry data including 'Older persons incidence of trauma' 5-Districts major trauma project.

Main areas of research
Multiple Sclerosis, Epilepsy, Parkinson’s disease, Stroke.

Contact
Kate Ives
Study Coordinator
neuroresearch@waikatodhb.health.nz

Active/recruiting research
Primary Progressive Multiple Sclerosis

Main areas of research

  • Induction of labour
  • Analgesia in labour
  • Steroids in pregnancy
  • Analgesia for outpatient hysteroscopy

Contacts

Dr R Foon
Dr N Titchiner
Jessica Jordan
Dr E Twidale – MACH

 

MACH
Methoxyflurane for conscious hysteroscopy, a randomized, double-blind, placebo-controlled trial. 

Fatigue after infusion or Transfusion (FIT) Pilot Trial
A pilot study as part of a research project on post-partum anaemia in New Zealand

Respiratory

The Respiratory research team consists of two consultants, at least one research fellow, two study coordinators/research nurses, and one administrative assistant.

We currently have a variety of studies in progress for a range of medical conditions including:

  • Asthma 
  • COPD
  • Bronchiectasis
  • Influenza A
  • Bronchiectasis
  • IPF
  • Alph1 Antitrypsin Deficiency
  • Colistridium Difficle
  • Community Acquired Pneumonia

Read more

Gastroenterology

The Gastro research team consists of two consultants, one research fellow, two study coordinators/research nurses, and one administrative assistant.

We currently have a variety of studies in progress for a range of medical conditions including:

  • Crohns Disease
  • Ulcerative Colitis
  • Hepatitis B & C
  • NASH
  • Primary biliary cholangitis

 

Main areas of research

  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Osteoarthritis
  • Gout
  • Systemic Lupus Erythematous
  • Scleroderma

Contact
Denise Darlington
Study Coordinator

Active /recruiting research

  • Gout
  • Sjogren’s Syndrome 
  • Scleroderma