RecruitingPHASE4INTERVENTIONAL

Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery

This study is looking into the best time to give medicine that prevents blood clots for people having surgery on their pancreas. Doctors are trying to figure out if it's better to give this medicine (called thromboprophylaxis) right before the operation or straight after. This is a really important question because pancreatic surgery carries risks of both blood clots and bleeding, and the timing of this preventative medicine can make a difference. Currently, different guidelines around the world suggest different approaches, and there isn't clear agreement based on strong evidence. This research aims to provide a clearer answer by carefully comparing both timings to improve patient safety and recovery after surgery.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Helsinki University Central Hospital

Enrolment target

800

Start

17 Aug 2022

Estimated completion

01 Sep 2026

Pancreas Cancer Pancreas Neoplasm Surgery Thrombosis Bleeding

What is this study about?

When someone has pancreatic surgery, there are a few important things doctors need to consider to keep them safe and help them recover well. Two main concerns are blood clots, which can be very serious, and bleeding. To help prevent blood clots, doctors often give special medicines. However, giving these medicines also carries a small risk of increasing bleeding.

Currently, doctors worldwide don't fully agree on the best time to give these clot-preventing medicines for pancreatic surgery – whether it should be before the operation or only after. Some guidelines suggest giving it beforehand, while others recommend waiting until after surgery. The problem is that there isn't much strong research that directly compares these two approaches, especially for pancreatic surgery where the risk balance between clots and bleeding can be quite delicate.

This study, therefore, aims to thoroughly investigate this question. By carefully comparing patients who receive the medicine before surgery with those who receive it after, researchers hope to find out which timing is safer and more effective. This will help doctors make better, more informed decisions for their patients in the future, improving outcomes for people undergoing pancreatic surgery.

Key takeaways

This study compares giving blood thinner medicine before or after pancreatic surgery.
It aims to find the best timing to prevent blood clots while managing bleeding risks.
Current guidelines for this timing are not consistent, so more research is needed.
The study uses standard blood clot prevention medicines already in common use.
Participation involves receiving your care at a specific, randomly assigned time for the preventative medicine.
This research could help improve patient safety and recovery after pancreatic surgery.

Who may be eligible?

This study is looking for adults aged 18 and over who are scheduled to have certain types of pancreatic surgery. This includes operations where parts of the pancreas, such as the head (pancreaticoduodenectomy), or the whole pancreas (total pancreatectomy), are removed for any medical reason. It also includes surgery to remove the tail of the pancreas (distal pancreatectomy) if there's a concern about cancer.

However, some people won't be able to join the study. This includes individuals who are already taking blood-thinning medication (like warfarin or certain new oral anticoagulants) within a month of their surgery. If your surgery is an emergency (for example, due to injury or a sudden infection), you also won't be eligible. Lastly, if you have an allergy to the specific type of blood-thinning medicine used in the study, or if you're unable to provide written permission (consent) to take part, then you won't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having pancreatic surgery to remove part or all of your pancreas?
Are you NOT currently taking blood-thinning medicines (e.g., warfarin) within a month of surgery?
Is your surgery planned, not an emergency?
Do you NOT have an allergy to common blood clot prevention medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups: one group will receive a blood clot prevention medicine just before your pancreatic surgery, and the other group will receive it just after your surgery. The specific medicines used are common ones like enoxaparin, tinzaparin, or dalteparin, which help prevent blood clots. You will continue to receive this medicine as your doctors usually recommend during your hospital stay.

Beyond receiving the medicine at a specific time, your usual hospital care for pancreatic surgery will continue as normal. This means you'll have your surgery, recovery, and follow-up as planned by your medical team. The study doesn't involve extra hospital visits or assessments that aren't part of standard care for this type of operation. The total duration of your participation will cover your hospital stay and recovery following your surgery.

Potential risks and benefits

Taking part in this study may offer a personal benefit by helping your doctors understand the most effective and safest way to prevent blood clots during pancreatic surgery. The main potential risks are those already associated with pancreatic surgery and the blood-thinning medicines themselves, which include a risk of bleeding and, less commonly, blood clots. These are risks that exist with or without the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care. Your decision will always be respected.

Locations (5)

Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada· Recruiting
Helsinki University Hospital
Verified postcode
Helsinki, Finland· Recruiting
Oulu University Hospital
Verified postcode
Oulu, Finland· Recruiting
Tampere University Hospital
Verified postcode
Tampere, Finland· Recruiting
Oslo University Hospital
Verified postcode
Oslo, Norway· Recruiting

Common questions

What is 'thromboprophylaxis'?

It's a medical term for treatments or medicines given to prevent blood clots from forming, especially after surgery.

What kind of pancreatic surgery is included?

The study is for people having operations like pancreaticoduodenectomy (Whipple procedure), total pancreatectomy, or distal pancreatectomy (removing the tail of the pancreas) for suspected cancer.

Are the medicines experimental?

No, the medicines used (like enoxaparin) are well-known and commonly used blood clot prevention medicines, not new experimental drugs.

Will I know if I get the medicine before or after surgery?

Yes, you and your doctors will know which treatment group you are in, as this is part of the care plan.

Who is funding this study?

The information provided doesn't specify the funding source. This is usually detailed in the full patient information sheet.

How to find out more

Ville Sallinen, MD,PhD

ville.sallinen@helsinki.fi +358-9-4711 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.