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Heparin

Clinical trials are investigating Heparin in different patient groups to see how well it works and how safe it is in real study settings. These studies include people with cancer, sepsis, pulmonary embolism, and those needing ECMO, and they look at survival, bleeding, clot reduction, and other key outcomes.

Table of Contents

Overview of the Heparin trials

The trials in this set are testing Heparin in different hospital settings and disease areas, not as a general medicine overview, but as part of specific research questions.[1][2]

Across the studies, researchers are looking at outcomes such as survival, clot reduction, bleeding, and the need for life-supportive therapies.[1][2]

Cancer-related studies

One Phase 2 trial in colorectal liver metastases is studying an extended criteria treatment approach for patients with a heavy tumour burden, and it lists Heparin among the infusion drugs used in the treatment plan.[1]

This study planned to enroll 97 patients and uses overall survival at two years as the main outcome.[1]

A separate Phase 3 trial in intra-hepatic cholangiocarcinoma is testing trans-arterial treatment for patients whose cancer is not suitable for surgical removal, and Heparin is part of the treatment regimen.[3]

This larger study planned to enroll 800 patients and measures median survival time, which is the middle point of survival times in the study group.[3]

Another Phase 3 study in colorectal liver metastases is testing hepatic arterial infusion pump chemotherapy combined with systemic therapy versus systemic therapy alone for initially unresectable disease, and Heparin is one of the study drugs.[4]

This trial planned to enroll 306 patients and uses overall survival as the main outcome.[4]

Critical care and clot-related studies

One Phase 2 trial called PALETTE is studying personalized sepsis treatment in children and adults, and Heparin is one of several possible study treatments.[2]

This study planned to enroll 2000 patients and measures two main outcomes: 28-day all-cause mortality and the number of days alive without life-supportive therapies at day 28 after randomization.[2]

Another Phase 3 trial, RATE, includes patients who receive ECMO during the study period in participating centers, with some exclusions for ECMO used only to bridge a procedure or surgery.[5]

In this study, Heparin is compared with nadroparin, and the main combined outcome includes major bleeding, severe thromboembolic complications, and mortality at 6 months.[5]

The STRATIFY II Phase 3 trial is studying patients with acute intermediate high-risk pulmonary embolism, and Heparin is part of one of the treatment groups.[6]

This study compares clot-reduction approaches and measures the modified Miller score, which reflects clot involvement and segmental blood flow in the lungs.[6]

Phases, enrollment, and study design

The trials are mostly interventional, meaning researchers actively assign treatments and compare outcomes.[1][2][3][4][5][6]

The set includes both Phase 2 and Phase 3 studies, with Phase 2 trials focused on earlier assessment and Phase 3 trials using larger groups and direct comparisons.[1][2][3][4][5][6]

Enrollment ranges from 97 patients in the smaller liver metastases study to 2000 patients in the sepsis study, showing that these trials vary a lot in size.[1][2]

Two trials are listed as suspended, while the others are authorised, which means their current study status is different.[1][2][3][4][5][6]

Main outcomes being measured

The main outcomes focus on what matters most to patients in serious illness: living longer, avoiding bleeding, avoiding clot problems, and spending more time without machines that support breathing, circulation, or kidney function.[1][2][5]

In the cancer studies, the main outcomes are survival-based, including overall survival and median survival time.[1][3][4]

In the intensive care and clot studies, the main outcomes include mortality, bleeding, thromboembolic complications, and clot burden scores.[2][5][6]

Who can participate

Eligibility depends on the trial, because each study is built for a different patient group.[1][2][3][4][5][6]

Some trials include people with specific cancers, some include patients with sepsis, and others include people receiving ECMO or treatment for pulmonary embolism.[1][2][3][4][5][6]

In the RATE study, patients whose ECMO is used only as a bridge to a procedure or surgery are excluded, so the study is not open to every ECMO patient.[5]

In STRATIFY II, the target group is patients with acute intermediate high-risk pulmonary embolism, which is a serious type of blood clot in the lungs.[6]

Trial ID Phase Condition studied Status Enrollment
NCT04898504 Phase 2 Colorectal Liver Metastases Suspended 97
2025-521371-31-00 Phase 2 Sepsis Authorised 2000
2023-504433-50-00 Phase 3 Intra-hepatic cholangiocarcinoma Authorised 800
2023-506194-35-00 Phase 3 Colorectal liver metastases Suspended 306
NCT00412524 Phase 3 ECMO treatment Authorised 330
2024-515712-45-00 Phase 3 Pulmonary embolism Authorised 210

FAQ

  • What kinds of conditions are being studied with Heparin? The trials study Heparin in several conditions, including colorectal liver metastases, sepsis, intra-hepatic cholangiocarcinoma, pulmonary embolism, and ECMO support. This shows that Heparin is being tested in very different hospital and cancer care settings.
  • Who may take part in these Heparin trials? The target groups differ by trial. Some studies include adults with cancer, some include children and adults with sepsis, and one study includes patients receiving ECMO, while another focuses on people with acute pulmonary embolism.
  • What phases are the Heparin trials in? The trials listed are mainly Phase 2 and Phase 3 studies. Phase 2 trials usually look more closely at early signs of benefit, while Phase 3 trials compare treatments in larger groups.
  • What are the main outcomes being measured? The studies measure outcomes such as overall survival, 28-day mortality, days alive without life-support, bleeding, thromboembolic complications, and clot reduction. These outcomes help show whether the study treatment changes how patients do over time.
  • Are all the Heparin trials active? No. Some trials are authorised, while others are suspended. The status tells you whether the study is currently moving forward or has been paused.

Ongoing Clinical Trials on Heparin

  • Study on the Effectiveness of Floxuridine and Drug Combination for Patients with Unresectable Colorectal Liver Metastases

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Effectiveness of Floxuridine with Gemcitabine and Oxaliplatin for Patients with Intra-hepatic Cholangiocarcinoma Not Suitable for Surgery

    Recruiting

    3 1 1 1
    Investigated drugs:
    Norway

  • Testing a Drug Combination for Personalized Sepsis Treatment in Children and Adults with Severe Blood Infection

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Heparin and Nadroparin Calcium for Patients Undergoing ECMO Treatment to Reduce Bleeding Risks

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    The Netherlands

  • Study on Treatment for Colorectal Liver Metastases Using Heparin, Dexamethasone, and Floxuridine for Patients with Heavy Tumor Burden

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway

  • Study on Treatments for Intermediate High-Risk Pulmonary Embolism: Comparing Percutaneous Embolectomy, Ultrasound-Assisted Thrombolysis with Alteplase, and Heparin

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Clinical trial: A research study in people that tests whether a treatment is safe, helpful, or better than another option.
  • Interventional study: A study where researchers give one or more treatments and then compare the results.
  • Phase 2: An early stage of testing that looks at whether a treatment may work and what effects it has in a smaller group.
  • Phase 3: A later stage of testing in a larger group, often used to compare treatments more directly.
  • Enrollment: The number of people planned to join the study.
  • Primary outcome: The main result the researchers want to measure, such as survival or bleeding.
  • Overall survival: How long patients live after treatment or after joining the study.
  • Mortality: Death rate in the study group during a set time period.
  • Life-supportive therapies: Treatments that help keep a patient alive, such as breathing support, heart support, or kidney support.
  • Thromboembolic complication: A problem caused by a blood clot that blocks blood flow, such as a stroke or limb ischemia.
  • ECMO: Extracorporeal membrane oxygenation, a machine that supports the heart and lungs when they cannot work well on their own.
  • Modified Miller score: A scoring system used to measure how much a clot affects the lungs and blood flow.

References

  1. https://clinicaltrials.gov/study/NCT04530578
  2. https://clinicaltrials.gov/study/NCT05148377
  3. https://clinicaltrials.gov/study/NCT00905216
  4. https://clinicaltrials.gov/study/NCT01589146
  5. https://clinicaltrials.gov/study/NCT00484822
  6. https://clinicaltrials.gov/study/NCT01651923
  7. https://clinicaltrials.gov/study/NCT01652638
  8. https://clinicaltrials.gov/study/NCT01234285
  9. https://clinicaltrials.gov/study/NCT03306836