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Thrombosis prophylaxis and coagulation activation during neoadjuvant treatment in pancreatic cancer - Association to prognosis and recurrence.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512475-12-01
Enrollment
214
Registered
2024-11-27
Start date
2024-11-27
Completion date
Unknown
Last updated
2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

We are investigating the efficacy and safety of enhanced thromboprophylaxis during neoadjuvant treatments for pancreatic cancer.

Brief summary

As primary endpoints, we collect venous and arterial thrombotic events, bleeding complications, as well as information on disease progression and feasible time and cause of death. Patients are followed for at least five years or until death.

Detailed description

We will observe changes in the patient's coagulation activation from venous blood samples during neoadjuvant treatment and disease follow-up. Blood samples will be taken before the start of neoadjuvant treatments, between chemotherapy cycles, after neoadjuvant treatments, and (or after the start of palliative treatments if surgery is not feasible) at months 1, 3, 6, 12, 15, 24, and 36 along with other scheduled blood tests.

Interventions

DRUGinnohep® 3500 anti-Xa IU injektioneste
DRUGliuos
DRUGkerta-annosruiskussa
DRUGInhixa 6
DRUG000 IU (60 mg)/0.6 mL solution for injection in pre-filled syringe

Sponsors

HUS-Yhtymae, University Of Helsinki
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
As primary endpoints, we collect venous and arterial thrombotic events, bleeding complications, as well as information on disease progression and feasible time and cause of death. Patients are followed for at least five years or until death.

Secondary

MeasureTime frame
We will observe changes in the patient's coagulation activation from venous blood samples during neoadjuvant treatment and disease follow-up. Blood samples will be taken before the start of neoadjuvant treatments, between chemotherapy cycles, after neoadjuvant treatments, and (or after the start of palliative treatments if surgery is not feasible) at months 1, 3, 6, 12, 15, 24, and 36 along with other scheduled blood tests.

Countries

Finland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026