Clinical trials and research units — Waikato

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 RCTs 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, Oxford University and Columbia University with various collaborative projects.

Areas of interest include:

• EEG during anaesthesia
• regional blockade
• 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.

Contact

For information about any of the above trials:

• email Jonathan Termaat: jonathan.termaat@waikatodhb.health.nz

There are multiple different subtypes of breast cancer, and the breast cancer research team coordinates clinical trials introducing:

• new surgical and radiotherapy techniques
• 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 to 4 clinical trials investigating new treatments or care to breast cancer across different disciplines, such as:

• breast surgery
• plastic surgery
• radiology
• medical or radiation oncology.

We coordinate clinical trials for:

• prevention
• treatment of ductal carcinoma insitu
• 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.

More information about trials in recruitment, follow-up or closed, is on the Breast Cancer Research Trust website.

Current clinical trials — Breast Cancer Research Trust (external link)

Breast Cancer Foundation national register — Midland 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 Aotearoa 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, Te Manawa Taki | Midland Health region and Aotearoa New Zealand.

More information about the national register is on the Breast Cancer Research Trust website.

Breast Cancer Foundation National Register — Breast Cancer Research Trust (external link)

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
• pancreatic.

Currently recruiting to 2 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)
• acute lymphoblastic leukemia (ALL).

Currently recruiting for CLL naïve trial and NHL trial.

We also support in-house, investigator-lead trials.

Contact

Email: 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.

Cancer clinical trials patient information booklet (PDF 420KB) [PDF, 421 KB]

Main areas of research

Our main areas of research are:

• 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 50 years. Cardiology patients in Waikato Hospital have participated in more than 140 international multi-centre trials, which have led to the evidence-based treatments that are used today.

Contact

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 Aotearoa 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 universities, to 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 or without coronary bypass graft
• trends of surgical ablation for AF in Aotearoa New Zealand
• 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 uutcomes 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 to 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 (external link)
• 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 (external link)
• 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 (external link)
• 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 (external link)
• 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 (external link)
• 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 (external link)
• 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 (external link)
• 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 (external link)
• 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 (external link)
• 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 (external link)
• 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 (external link)
• 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 (external link)
• 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 (external link)
• 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 (external link)

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

Contact

Email Kelly Henderson: kelly.henderson@waikatodhb.health.nz

Main area of research

• Critical care.

Active and recruiting research

• REMAP-CAP — randomised embedded multi-factorial adaptive platform trial of community-acquired pneumonia.
• MEGA-ROX — mega randomised registry trial comparing conservative versus 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.

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, multi-centre, 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 — BLING III randomised clinical trial.
• FAB study — fluid after bypass study.
• Gallus NIV mask trial — with Fisher & Paykel.
• BALANCE — bacteremia antibiotic length actually needed for clinical effectiveness — a prospective multic-entre, 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

The main areas of diabetes research are:

• cardiovascular disease
• kidney disease
• hypertension
• diabetic retinopathy
• neuropathy
• glucose control
• devices for glucose monitoring and insulin delivery
• diabetes and driving.

Active/recruiting research

Diabetes and kidney disease: 2 studies.

Completed studies

Diabetes and cardiovascular outcomes.

Contact

Annie Johnstone
Study Coordinator

Phone: 021 240 9087
Email: annie.johnstone@waikatodhb.health.nz

Main areas of research

The main areas of research are:

• multiple sclerosis
• epilepsy
• Parkinson's disease
• stroke.

Active/recruiting research

Primary progressive multiple sclerosis.

Contact

Kate Ives
Study Coordinator

Email: neuroresearch@waikatodhb.health.nz

Main areas of research

The main areas of research are:

• induction of labour
• analgesia in labour
• steroids in pregnancy
• analgesia for outpatient hysteroscopy.

Active research

• MACH — methoxyflurane for conscious hysteroscopy: a randomised, 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 Aotearoa New Zealand.

Current studies

• ARROW trial for recurrent wheeze or asthma in preschool children.
• PRECARE trial — for preschool children with mild asthma or recurrent wheeze.

Main areas of research

• Recurrent wheeze or asthma in childhood.
• Bronchiolitis.
• Medical conditions in child health.

Contact

Email: waikidsresearch@waikatodhb.health.nz

Contact

Phone: 07 839 8976

Email: renalresearch@waikatodhb.health.nz

Respiratory

The respiratory research team consists of:

• 2 consultants
• at least 1 research fellow
• 2 study coordinators/research nurses
• 1 administrative assistant.

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

• asthma 
• COPD
• bronchiectasis
• influenza A
• IPF
• alpha-1 antitrypsin deficiency
• colistridium difficle
• community acquired pneumonia.

Gastroenterology

The gastro research team consists of:

• 2 consultants
• 1 research fellow
• 2 study coordinators/research nurses
• 1 administrative assistant.

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

• Crohn's disease
• ulcerative colitis
• hepatitis B & C
• NASH
• primary biliary cholangitis

Main areas of research

The main areas of research are:

• rheumatoid arthritis
• psoriatic arthritis
• osteoarthritis
• gout
• systemic lupus erythematous
• scleroderma.

Active and recruiting research

Active and recruiting research includes:

• gout
• Sjögren's syndrome
• scleroderma.

Main areas of research

High quality data to provide a picture of trauma in our community, using the Midland | Te Manawa Taki Trauma Registry and clinical trials involving trauma patients.

Trauma Registry — Te Manawa Taki Trauma System (external link)

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.

Contact

Grant Christey
Trauma Director

Phone: 021 761 941