SPECIAL EDITION APPRECIATION FOR IMAGING SOCIETY IMAGING STAFF THE CLOTS TRIAL NEEDS YOU

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CLOTS Newsletter Special Imaging Edition, 2011 SPECIAL EDITION APPRECIATION FOR IMAGING SOCIETY IMAGING STAFF THE CLOTS TRIAL NEEDS YOU Imaging staff are a vital part of the CLOTS 3 team. We would recommend that anyone taking an active role in the CLOTS 3 trial have taken the time to read the protocol, look at the 8 minute video (we can provide a CD copy) on the devices and then do the CLOTS online quiz. Have you completed the online quiz? We have questions specifically aimed at imaging staff (select your role as radiographers, radiologists and technicians involved in scanning from the drop down box when registering). The Hospital Co-ordinator can also keep a copy of the certificate in the site file to show evidence of the teams knowledge and understanding of the trial and you can keep a copy for your CPD file. Consider putting the name of the main imaging contact on the delegation log. We are not an IMP so we do not need to see the delegation log, but it is good clinical practice to keep this updated. THE IMPORTANCE OF DOPPLERS CARRIED OUT WITHIN THE REQUIRED TIMEFRAME It is important that leg Dopplers are carried out between days 7-10 and days 25-30 after randomisation. It is a protocol violation if Dopplers are carried outwith the required timeframe. We can not accept early Dopplers and you will be required to repeat the scan should the trial Doppler be carried out before day 7 or day 25. If however for any valid reason the Doppler has to be delayed please arrange this as soon as possible. We will include late Dopplers in our analyses. Please notify the CLOTS Co-ordinating Centre in advance of any Dopplers that will be carried out late. If a patient does not have a Doppler carried out the patient has not contributed to the trial, it reduces the power of the trial and no payment will be available. Report back the Doppler result ASAP - Please Turn Over

REPORT BACK THE DOPPLER RESULT ASAP Once the Doppler has been carried out a CLOTS radiology report form should be completed and faxed to the CLOTS Coordinating Centre or the result can be entered online via the CLOTS website as soon as possible (or we will start chasing you for it). Please ensure you complete all fields of the CLOTS radiology report form before returning to the CLOTS Co-ordinating Centre as we will query any missing answers. We have found the most common missing answers are in the last section, please ensure you complete the person doing the scan, their role and also the name of the person completing the form. This is source data and should be completed correctly. To enter results online go to the CLOTS home page (www.clotstrial.com) select the report a leg vein examination button. You will be directed to the screen below, select your centre from the drop down list and enter two pieces of information to identify the patient (initials, date of birth, CLOTS ID). Remember to hit the submit button to store the data. When is DVT Evidence Required - Please Turn Over

WHEN IS DVT EVIDENCE REQUIRED If a patient has a positive Doppler (above knee DVT in the femoral or popliteal) this is our primary outcome therefore a picture is required as evidence. An image, either video or still, should be sent to the CLOTS Co-ordinating Centre via CD, paper or email images from NHS email account to NHS email account (janie.hunter@nhs.net). If the patient has a positive first Doppler above knee DVT (in the femoral or popliteal) a 2nd Doppler is not required. The 2nd Doppler can only be cancelled when the CLOTS Co-ordinating Centre receive the completed CLOTS radiology report form and an image of the DVT from the 1st Doppler performed. If the patient has a positive first Doppler below knee DVT (in the calf) an image is not required and the 2nd Doppler should be carried out. All above knee DVT evidence is reviewed by an independent radiologist. 1 st Doppler Result Location of DVT Image Required? 2 nd Doppler Required? Positive above knee DVT Femoral or Popliteal YES NO (2 nd Doppler can be cancelled when the CLOTS Co-ordinating Centre receive the completed CLOTS radiology report form and an image of the DVT from the 1 st Doppler.) Positive below knee DVT Calf NO YES No DVT present NO YES CLOTS Imaging Heroes - Please Turn Over

CLOTS IMAGING HEROES JONATHON YATES Stroke Research Nurse, Kay Finnie has nominated Jonathon Yates, Advanced Practitioner, Ultrasound Department as an imaging hero at the University Hospital of North Staffordshire. Jon is extremely keen to be involved in the CLOTS study and literally goes out of his way by visiting patients in his own time to scan them at one of the Rehab hospitals. Prior to him becoming part of the CLOTS team we experienced difficulty in arranging for the scans to be conducted, but since he has been involved he has never failed to scan a patient on or around the due date and always completes the imaging forms and enters the data on the electronic CRF personally. If he takes annual leave we are always kept informed and provided with alternative contacts who will attend to the participant in his absence. When we have participants that have been discharged home who require their scan as an outpatient he is consistently obliging and even arranges the taxi home for the individuals after the scan. He is currently part of a drive to extend Doppler scanning into other cottage / rehab hospitals so that the service they provide can be enhanced further. He deserves a medal for his enthusiasm and dedication and receiving this award would be an excellent way to demonstrate our appreciation of his continued services. DR GURMEET JUTLLA Dr Sekaran at Luton & Dunstable NHS Foundation Trust has nominated Consultant Radiologist, Dr Gurmeet Jutlla for his continuous unstinted support for CLOTS 3 as he has done for CLOTS 1. ANGELA HOPKINS & LOUISE WILCOX Stroke Research Nurse Jane Hunt nominated Radiology Administrator, Angela Hopkins who has gone out of her way in trying to accommodate our CLOTS patients for their Dopplers, especially when they have been transferred to our community rehab ward. She is very conscientious and tries to book times around travelling considerations and mealtimes and puts up with us wanting to rearrange appointments. Also, our Sonographer, Louise Wilcox, who has been brilliant with performing the Dopplers and reporting the scans for us. More CLOTS Imaging Heroes - Please Turn Over

CLOTS IMAGING HEROES (continued) SUE-CAROL COLE, KATE LLOYD, LESLEY BARTLETT, DENZIL PEREIRA & DEBORAH DOLLING Cheryl.Padilla-Harris has nominated the imaging team at Milton Keynes Hospital I work with a wonderful Imaging team who really deserve a medal for their collaborative effort to help the CLOTS 3 trial run smoothly at Milton Keynes hospital. Sue-Carol Cole (Imaging Medical Secretary) makes the Doppler appointments promptly and never forgets to email me with dates and times. Sue-Carol also keeps me updated with any new developments such as difficulties with getting the patient from the ward to the ultrasound department. The team of Sonographers: Kate Lloyd, Lesley Bartlett, Denzil Pereira and Deborah Dolling help prevent delays by phoning me if there is a problem or any issue I should be aware off and are very accommodating with doing the scans e.g. an outpatient cancelled her CLOTS 3 Doppler scan at short notice but she was able to have it rescheduled for later in the day. The radiology report forms are always completed on the same day which helps me tremendously so that I can update the database in a timely fashion. Above all, good communication helps keep things running smoothly and for this I am really grateful. Left to right: Sue-Carol Cole (Imaging Medical Secretary), Kate Lloyd (Superintendent Radiographer), Deborah Dolling (Superintendent Radiographer), Denzil Pereira (Senior Radiographer) and Lesley Bartlett (Senior Sonographer). More CLOTS Imaging Heroes - Please Turn Over

CLOTS IMAGING HEROES (continued) CLAIRE MAYALL Stroke Research Nurse, Rachel Teal at John Radcliffe Hospital writes I would like to tell you about Maundy Thursday here in Oxford, and the person, and team I think who deserve medals. I had a patient at Witney, one of our rehab sites whose day 7-10 Doppler was due between Maundy Thursday and Easter Sunday. Naturally I wanted to get it done on time, but that really only left the Thursday as an option. Witney does have a bi-weekly Doppler facility, staffed by the John Radcliffe sonographer's. However at times, like holiday periods when their staffing numbers are reduced, they have to prioritise and just provide cover for the John Radcliffe, so the clinic at Witney gets cancelled, and patients requiring urgent Dopplers get sent to the John Radcliffe for the procedure. The radiologists had cancelled the clinic at Witney, but when I expressed my concern that hospital transport might not be available due to the amount of patients who like to get home for the holiday season, one, Claire Mayall, offered to go into Witney for 9am especially to do the leg doppler, and then come to the John Radcliffe afterwards. I was so pleased that she suggested this, as not only did it spare the patient a ambulance trip, it also meant it could definitely be done on time rather than being delayed until after the bank holidays the next week. So, please thank Claire for literally gong out of her way to help that day, and please thank the team who have all been so supportive of both CLOTS 2 and CLOTS 3. DR KIERAN MCBRIDE Katrina McCormick, Stroke Research Nurse would like to recommend Dr McBride on behalf of NHS Fife. Dr McBride the Consultant Radiologist at Queen Margaret Hospital does the scans and is very accommodating. Fitting in CLOTS Dopplers around his clinic lists (and on occasions lunch breaks). He has also been known, if for reasons where patients have been unable to leave the ward, to take the USS to the ward and do the scans there. PAULINE FITZELL Rachel Walker, AVS. Vascular Laboratory, Torbay Hospital has nominated Pauline Fitzell as a CLOTS Hero. Pauline and the Stroke Research Team at Torbay are always highly efficient and helpful in organising all the necessary arrangements for trial patients coming for scans in the Vascular Laboratory. Pauline and her team always do everything they can to make sure that everything goes smoothly for the scanning staff as well as for the patients and their carers or relatives. CLOTS 3 Message Board - Please Turn Over

TORBAY HOSPITAL We don t often encounter any particular problems with scanning the CLOTS Trial patients at Torbay Hospital, largely due to the highly efficient communication and planning by Pauline Fitzell, our local trial coordinator, and the rest of the Stroke Research Team. The only issue that has occasionally caused us some challenges is scanning those patients who have very restricted mobility following their stroke. In such cases it is imperative that the patient is brought for their scan on a bed, is appropriately dressed in a gown or nightdress allowing full access to the legs and comes with at least one escort. In these cases, moving the patient can be challenging and assistance of one or more individuals may be required to help position and support the leg - particularly to facilitate scanning of the popliteal and calf veins. In my own experience with the CLOTS Trial to date the majority of thromboses I have picked up have been in the below-knee veins. This being the most challenging part of the scan anyway makes it all the more important to be able to optimise the position of the leg effectively to achieve the best images in these less mobile patients. CLOTS 3 Message Board If you have an article that you would like included in a future CLOTS newsletter contact us at: THE CLOTS TRIAL CO-ORDINATING CENTRE Neurosciences Trials Unit, Western General Hospital Edinburgh, Scotland, EH4 2XU Helpline - 0131 537 1082 Fax - 0131 3325150 Website - www.clotstrial.com Email - clots@skull.dcn.ed.ac.uk ROYAL BOURNEMOUTH & CHRISTCHURCH NHS TRUST Radiology are a great support to us. We have already nominated Angie from Medical Physics as our clots hero. Our main problem is patients moving to the rehab site at short notice, when the Doppler is booked at the main site. Radiology are always very helpful when this happens. It does cause delays in the Dopplers being done sometimes. We would like to say that the CLOTS trial has helped three of our patients here recently, all of whom had asymptomatic above knee DVTs identified on Doppler and they all had IVC filters inserted. This would not have been identified without the CLOTS trial. Anna Orpen, Lead Stroke Research Nurse Rachel Walker, Vascular Laboratory