Clinical trials and research units

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

Main areas of research
There are multiple subtypes of breast cancer and we coordinate clinical trials introducing new surgical, radiotherapy and drug treatments for the different types of this disease. In addition we run the Waikato Breast Cancer Register, and coordinate local PhD and other research.

Contacts
Jenni Scarlet
Fiona Johnson

Waikato Breast Cancer Research Trust

Phone: 07 839 8726 ext 97916 or ext 97845
www.wbcrt.org.nz  

Active /recruiting research

• POSNOC trial - POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy.
• ROLLIS trial - Can Radio-guided Occult Lesion Localisation using Iodine-125 Seeds (ROLLIS) for excision of impalpable breast cancer reduce the rate of pathologically inadequate margins and/or subsequent oncological surgery compared with standard hook-wire localisation? A randomised controlled trial.

Completed research

• International Breast cancer Intervention Study (IBIS) II Prevention and IBIS II DCIS trials.
• SOFT - Supression of Ovarian Function Trial.
• TAILORx – Trial Assigning Individualised Options for Treatment.
• SOLE - Study Of Letrozole Extension trial.
• SNAC2  - Sentinel Node biopsy versus Axillary Clearance trial.
• QoLID - Quality of Life study of Immediate and Delayed breast reconstruction.
• SUPREMO Selective Use of Postoperative Radiotherapy After Mastectomy trial.

Main areas of research

• Medical Oncology Phase I-III: currently recruiting for melanoma, advanced solid tumours, non-small cell lung cancer, renal cell carcinoma, urothelial cancer, oestrogen receptor positive breast cancer.
• Radiation Oncology: currently recruiting for bladder cancer.
• Haematology, malignant and non-malignant: currently recruiting for acute myeloid leukaemia (AML), multiple myeloma, paroxysmal nocturnal haemoglobinuria (PNH).
• 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 to build collaborative partnerships on projects.

Current research areas of interest:

• Aortic Disease
• Rheumatic disease
• Clinical Trials:
  • Humidified CO2 Study: Effect of insufflation techniques on de-airing during valve surgery. 

Audits

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

Collaborative projects

• 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.
• CLIPNZ-II: cryopreserved versus liquid platelets
• RespirAq Study:  Humidifier usability during invasive ventilation

Contact 

Mr Nishith Patel - Cardiothoracic Surgeon
Kelly Henderson - Research Coordinator

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

Recent Publications 

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

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

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

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  

El-Gamel A. (2021). Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation: Challenging Pathology Awaiting Specialized Devices. Aorta (Stamford, Conn.), 9(2), 56–59. https://doi.org/10.1055/s-0041-1725122   

El-Gamel A. (2021). Redo CABG: Where Every Ounce of Experience Matters Regardless of the Technique. Heart, lung & circulation, 30(9), 1277–1280. https://doi.org/10.1016/j.hlc.2021.06.449

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., Barton, C., Page, S., Ganesh, J. S., Patel, N., Pirone, F., Lin, Z., Kejriwal, N. K., El Gamel, A., McCormack, D. J., & Meikle, F. (2021). Cardiac surgery simulation: a low-cost feasible option in an Australasian setting. ANZ journal of surgery, 91(10), 2042–2046. https://doi.org/10.1111/ans.17077

Singh, N., Gimpel, D., Manikavasagar, V., Watson, N., Roberts, J., Conaglen, P., Meikle, F., Lin, Z., Kejriwal, N., Odom, N., McCormack, D. J., & El-Gamel, A. (2021). Performance of the AusSCORE II and STS Score for Coronary Artery Bypass Grafting in a New Zealand Population. Heart, lung & circulation, 30(4), 600–604. https://doi.org/10.1016/j.hlc.2020.08.021

El-Gamel, A., & Chan, B. (2021). Full Metal Jacket Endarterectomy of Left Anterior Descending Coronary Artery is Safe With Good Midterm Outcomes. Heart, lung & circulation, 30(4), 605–611. https://doi.org/10.1016/j.hlc.2020.08.007  

El-Gamel A. (2021). Tricuspid Valve Prosthesis Choice: The Only Railroad to the Truth is to Conduct a Randomised Controlled Trial. Heart, lung & circulation, 30(3), 321–323. https://doi.org/10.1016/j.hlc.2021.01.003  

Haran, C., Gimpel, D., Clark, H., & McCormack, D. J. (2021). Preoperative Neutrophil and Lymphocyte Ratio as a Predictor of Mortality and Morbidity After Cardiac Surgery. Heart, lung & circulation, 30(3), 414–418. https://doi.org/10.1016/j.hlc.2020.05.115  

Sharma, V. J., Prakash, M., Lin, Z., & Lo, C. (2021). What are the endovascular options and outcomes for repair of ascending aortic or aortic arch pathology?. Interactive cardiovascular and thoracic surgery, 32(1), 106–110. https://doi.org/10.1093/icvts/ivaa215  

Prakash, M., Sharma, V., Kang, R., & Meikle, F. (2021). Airway compromise from subcutaneous emphysema. ANZ journal of surgery, 91(6), E421–E422. https://doi.org/10.1111/ans.16477 

Hogan, A. M., Ibrahim, S., Moylan, M. J., Mccormack, D. J., Openshaw, A. M., Cormack, F., & Shipolini, A. (2020). A prospective five-year cohort study of undiagnosed sleep apnea in patients undergoing coronary artery bypass graft surgery. The Journal of cardiovascular surgery, 61(5), 648–656. https://doi.org/10.23736/S0021-9509.20.11200-X

Prakash, M., & Meikle, F. (2020). How to create negative pressure wound dressing with wall suction: novel treatment of subcutaneous emphysema with PICO dressing. ANZ journal of surgery, 10.1111/ans.16365. Advance online publication. https://doi.org/10.1111/ans.16365

El-Gamel A. (2020). The Ideal Heart Valve: To Suture or Not to Suture, Is That the Question?. Heart, lung & circulation, 29(9), 1270–1272. https://doi.org/10.1016/j.hlc.2020.07.004

Prakash, M., Ong, Q., Lo, C., Macemon, J. B., & El Gamel, A. (2020). Rib Cage Stabilisation With 3D-Printed Polyethylene Sternal Prosthesis Post-Sternotomy Mediastinitis. Heart, lung & circulation, 29(10), 1561–1565. https://doi.org/10.1016/j.hlc.2020.01.005 

Macemon, J. B., Gimpel, D. J., & Kejriwal, N. K. (2020). Right ventricle laceration at laparoscopic foramen of Morgagni hernia repair. ANZ journal of surgery, 90(5), 924–925. https://doi.org/10.1111/ans.15748

Sharma, V. J., Prakash, M., Pirone, F., Chan, B., & Lin, Z. (2020). Type A aortic dissections: challenges of atypical presentation in remote New Zealand. The New Zealand medical journal, 133(1512), 99–101.

Lawrenson, R., Lao, C., Brown, L., Moosa, L., Chepulis, L., Keenan, R., Kidd, J., Middleton, K., Conaglen, P., de Groot, C., Aitken, D., & Wong, J. (2020). Management of patients with early stage lung cancer - why do some patients not receive treatment with curative intent?. BMC cancer, 20(1), 109. https://doi.org/10.1186/s12885-020-6580-6

Gimpel, D., Magoye, T., McCormack, D. J., El-Gamel, A., & Kejriwal, N. (2020). Inadvertent puncture of right ventricle during chest tube insertion. ANZ journal of surgery, 90(3), 376–378. https://doi.org/10.1111/ans.15132

Main areas of research
Critical care

Contacts
Kara Trask 
Amelia Butler

Active/recruiting research

• 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.
• REMAP- CAP- Randomised Embedded Multifactorial Adaptive Platform Trial of Community-Acquired Pneumonia.
• The NAC-ICU trial - Nebulised Acetylcysteine vs Nebulised Saline in invasively ventilated ICU patients with significant secretions burden 

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

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

• Cancer clinical trials patient information booklet [PDF, 421 KB]

Contact
Beula Vincent
Nurse Coordinator

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

• Ankylosing spondylitis - one trial
• Psoriatic arthritis – two trials.