Pancreas CancerPhase 4PREPOSTEROUS2NCT05245877
Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery
A Phase 4 study testing enoxaparin/tinzaparin/dalteparin in people with Pancreas Cancer and Pancreas Neoplasm, run by Helsinki University Central Hospital at 5 sites in 3 countries.
Trial summary
Thromboprophylaxis for pancreatic surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in pancreatic surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing pancreatic surgery. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pancreas Cancer, Pancreas Neoplasm, Surgery
- What is being tested?
- enoxaparin/tinzaparin/dalteparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 17 Aug 2022to Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing either
- pancreaticoduodenectomy or total pancreatectomy (for any indication) or
- distal pancreatectomy for suspicion of cancer
Who cannot join
- Patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during the month (30 days) preceding surgery
- Emergency operation (e.g. for trauma, infection or pancreatitis)
- Age < 18 years
- Allergy or other contraindication to planned low-molecular weight heparin
- Inability to give written informed consent
- Pancreatic resection not performed (removed from analyses after randomization)
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
Finland3 sites, 3 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Tea Kontio, MD,PhD, tea.kontio@hus.fi
- Recruiting
Oulu University Hospital
Oulu
Minna Nortunen, MD, PhD, +358 8 3152011, minna.nortunen@ppshp.fi
- Recruiting
Tampere University Hospital
Tampere
Johanna Laukkarinen, MD, PhD, Professor, +358 3 311 61, johanna.laukkarinen@pirha.fi
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto
Paul Karanicolas, 416-480-6100, paul.karanicolas@sunnybrook.ca
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo
Knut J Labori, MD, PhD, Professor, +47 22 11 80 80, uxknab@ous-hf.no
About this study
Official title: Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery - a Prospective, Multicenter, Randomized Controlled Trial (PREPOSTEROUS Pancreas Trial)
Thromboprophylaxis for pancreatic surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in pancreatic surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing pancreatic surgery. There are no prospective randomized trials in this field, and current guidelines are unfortunately based on very low quality evidence, that is, a few retrospective studies and expert opinion. Both American and European thromboprophylaxis guidelines for abdominal cancer surgery support the preoperative initiation of thromboprophylaxis, but these guidelines do not specifically address the increased bleeding risk associated with pancreatic surgery. On the contrary, Dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. Enhanced Recovery After Surgery (ERAS) Society Guidelines recommend preoperative thromboprophylaxis in pancreatic surgery, but the guidelines provide no supporting evidence for this recommendation. Overall, the amount of evidence is scarce and somewhat contradictory in this clinically relevant field of thromboprophylaxis in pancreatic surgery. The aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in pancreatic surgery in a randomized controlled trial.
- Conditions
- Pancreas Cancer, Pancreas Neoplasm, Surgery, Thrombosis, Bleeding
- Being tested
- enoxaparin/tinzaparin/dalteparin
- Medical subject headings
- Pancreatic Neoplasms, Thrombosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enoxaparin/tinzaparin/dalteparinDrug
Patients randomized to the preoperative thromboprophylaxis will have their thromboprophylaxis initiated approximately 2-14 hours prior to the planned pancreatic surgery skin incision (depending on the center's current practice and logistics). Thromboprophylaxis can be initiated using enoxaparin (20 - 40 mg), tinzaparin (2500 - 4500 IU), or dalteparin (2500 - 5000 IU), with the dose based on patient's renal function according to the local standard of care. A center may reduce the dose 25-50% if the dose is given very close to the skin incision (i.e. at the morning of the operation instead of the evening before the operation).
| Study group | Role | What they receive |
|---|---|---|
| Preoperative thromboprophylaxis | Experimental | Preoperatively initiated tromboprophylaxis Receives: Drug: enoxaparin/tinzaparin/dalteparin |
| Postoperative thromboprophylaxis | No intervention | Postoperatively initiated thromboprophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolism, number of patients
Number of patients that have venous thromboembolism, which include any of the following: 1) symptomatic deep venous thromboembolism (including all deep veins e.g. all extremities, portal-, and superior mesenteric vein) diagnosed using ultrasound or computed tomography or magnetic resonance imaging, or in re-laparotomy/surgery, 2) pulmonary embolism diagnosed using computed tomography, magnetic resonance imaging, or lung perfusion imaging, or 3) death due to venous thromboembolism.
Measured: within 30 days from pancreatic resection
Secondary outcomes (5)
Postpancreatectomy hemorrhage (PPH)
Postpancreatectomy hemorrhage (PPH), any grade in ISGPS classification for postpancreatectomy hemorrhage, number of patients
Measured: within 30 days from pancreatic resection
Comprehensive Complication Index - score
Comprehensive Complication Index - score
Measured: within 30 days from pancreatic resection
Length of postoperative hospital stay,
Length of postoperative hospital stay, days, within 30 days from pancreas resection including hospital stay due to readmission(s)
Measured: within 30 days from pancreatic resection
Transfused red blood cells
Total amount of transfused red blood cells, units, during and within 30 days from pancreas resection
Measured: during and within 30 days from pancreas resection
Post-operative hemoglobin below 70 g/l
Number of patients with post-operative hemoglobin below 70 g/l
Measured: during and within 30 days from pancreas resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start17 Aug 2022
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ville Sallinen, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245877
- Sponsor's protocol ID
- HYKS-PREPOSTEROUS2
- Acronym
- PREPOSTEROUS2
- Status last verified
- Feb 2025
- First submitted
- 29 Dec 2021
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery - a Prospective, Multicenter, Randomized Controlled Trial (PREPOSTEROUS Pancreas Trial)
- ClinicalTrials.gov ID
- NCT05245877
- Acronym / sponsor ID
- PREPOSTEROUS2 / HYKS-PREPOSTEROUS2
- Conditions
- Pancreas Cancer, Pancreas Neoplasm, Surgery, Thrombosis, Bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thromboprophylaxis for pancreatic surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in pancreatic surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing pancreatic surgery. There are no prospective randomized trials in this field, and current guidelines are unfortunately based on very low quality evidence, that is, a few retrospective studies and expert opinion. Both American and European thromboprophylaxis guidelines for abdominal cancer surgery support the preoperative initiation of thromboprophylaxis, but these guidelines do not specifically address the increased bleeding risk associated with pancreatic surgery. On the contrary, Dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. Enhanced Recovery After Surgery (ERAS) Society Guidelines recommend preoperative thromboprophylaxis in pancreatic surgery, but the guidelines provide no supporting evidence for this recommendation. Overall, the amount of evidence is scarce and somewhat contradictory in this clinically relevant field of thromboprophylaxis in pancreatic surgery. The aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in pancreatic surgery in a randomized controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative thromboprophylaxis | Experimental | Drug: enoxaparin/tinzaparin/dalteparinPreoperatively initiated tromboprophylaxis |
| Postoperative thromboprophylaxis | No intervention | –Postoperatively initiated thromboprophylaxis |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients undergoing either
- pancreaticoduodenectomy or total pancreatectomy (for any indication) or
- distal pancreatectomy for suspicion of cancer
Key exclusion criteria (6 listed)
- Patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during the month (30 days) preceding surgery
- Emergency operation (e.g. for trauma, infection or pancreatitis)
- Age < 18 years
- Allergy or other contraindication to planned low-molecular weight heparin
- Inability to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enoxaparin/tinzaparin/dalteparinPatients randomized to the preoperative thromboprophylaxis will have their thromboprophylaxis initiated approximately 2-14 hours prior to the planned pancreatic surgery skin incision (depending on the center's current practice and logistics). Thromboprophylaxis can be initiated using enoxaparin (20 - 40 mg), tinzaparin (2500 - 4500 IU), or dalteparin (2500 - 5000 IU), with the dose based on patient's renal function according to the local standard of care. A center may reduce the dose 25-50% if the dose is given very close to the skin incision (i.e. at the morning of the operation instead of the evening before the operation). | Drug | Preoperative thromboprophylaxis |
Primary outcome
Venous thromboembolism, number of patients
Time frame: within 30 days from pancreatic resection
Number of patients that have venous thromboembolism, which include any of the following: 1) symptomatic deep venous thromboembolism (including all deep veins e.g. all extremities, portal-, and superior mesenteric vein) diagnosed using ultrasound or computed tomography or magnetic resonance imaging, or in re-laparotomy/surgery, 2) pulmonary embolism diagnosed using computed tomography, magnetic resonance imaging, or lung perfusion imaging, or 3) death due to venous thromboembolism.
5 secondary outcomes
Postpancreatectomy hemorrhage (PPH)
Time frame: within 30 days from pancreatic resection
Comprehensive Complication Index - score
Time frame: within 30 days from pancreatic resection
Length of postoperative hospital stay,
Time frame: within 30 days from pancreatic resection
Transfused red blood cells
Time frame: during and within 30 days from pancreas resection
Post-operative hemoglobin below 70 g/l
Time frame: during and within 30 days from pancreas resection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing enoxaparin/tinzaparin/dalteparin in people with Pancreas Cancer and Pancreas Neoplasm, run by Helsinki University Central Hospital at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland, Canada, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ville Sallinen, MD,PhD (+358-9-4711, ville.sallinen@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous thromboembolism, number of patients (time frame: within 30 days from pancreatic resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.