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Human Fibrinogen

Clinical trials are studying Human Fibrinogen in different bleeding-related settings, including surgery, stroke after thrombolysis, and blood disorders. These studies look at whether it can help reduce bleeding, lower transfusion needs, and improve clotting-related outcomes in specific patient groups.

Table of contents

Clinical trial overview

The source data includes interventional studies, which means the researchers give a treatment and then measure the results.[1]

Most of the trials are in Phase 3, while two are in Phase 2.[1]

The studies look at Human Fibrinogen in settings where bleeding, clotting problems, or blood product use are important outcomes.[1]

Trials in surgery and bleeding control

One Phase 3 trial studies a fibrin adhesive in people having total gastrectomy for cancer, with the goal of lowering esophagojejunal anastomosis dehiscence, which means the surgical join between the esophagus and jejunum opens or breaks down after surgery.[1]

This study is randomized and multicenter, and it plans to enroll 240 people.[1]

Its main outcome is dehiscence diagnosed within the first seven days after surgery using clinical and/or radiological findings, with the Csendes classification used for assessment.[1]

Another Phase 3 study looks at bleeding in patients undergoing complex cardiac surgery with cardiopulmonary bypass, comparing fibrinogen concentrate plus standard care with placebo plus standard care.[1]

The main goal is to reduce the need for allogeneic blood products, which are blood components given from a donor, during the first 24 hours after treatment.[1]

This study plans to enroll 180 patients.[1]

Trials in stroke after thrombolysis

One Phase 3 pilot randomized controlled trial studies fibrinogen replacement in ischemic stroke patients who develop secondary post-rtPA hypofibrinogenemia, which means low fibrinogen levels after clot-busting treatment.[1]

The study aims to see whether fibrinogen infusion can reduce intracranial hemorrhage, which is bleeding inside the skull.[1]

It also measures symptomatic intracranial hemorrhage using NINDS, ECASS, and SITS classifications, as well as extracerebral bleeding outside the brain.[1]

The trial plans to enroll 200 patients.[1]

Trials in blood disorders and chemotherapy

One completed Phase 2 pilot single-center study, called the FORMAT Study, looked at thrombopenic patients with hematological malignancy after intensive chemotherapy who were refractory to platelet transfusion.[1]

Thrombopenic means having a low platelet count, and platelets are blood cells that help stop bleeding.[1]

The study tested fibrinogen together with platelet transfusion and used the ROTEM method to check clotting changes.[1]

The main outcome was the change in maximum clot elasticity, which was derived from maximum clot firmness on the EXTEM curve.[1]

The trial included 10 patients and focused on people with grade I or higher bleeding signs according to the WHO classification, modified by Slichter.[1]

Trial in very high-risk T-cell acute lymphoblastic leukemia

One Phase 2 study in adults with very high-risk T-lineage acute lymphoblastic leukemia includes Human Fibrinogen as part of a larger treatment program with daratumumab and chemotherapy.[1]

This trial plans to enroll 31 patients.[1]

The main endpoint is MRD negativity after induction, meaning the study checks whether minimal residual disease is not found at a very low level after the first treatment cycle.[1]

This is not a bleeding study only; it measures how well the leukemia treatment works in this high-risk group.[1]

Main endpoints and what they mean

The endpoints across these trials focus on practical patient outcomes such as bleeding, clot strength, transfusion needs, and early surgical healing problems.[1]

In surgery studies, the key outcomes include dehiscence and the number of blood product units given after treatment.[1]

In the stroke study, the main outcomes are intracranial hemorrhage, symptomatic intracranial hemorrhage, and extracerebral bleeding.[1]

In the chemotherapy-related study, the focus is on ROTEM clotting measurements, especially maximum clot elasticity.[1]

In the leukemia study, the endpoint is treatment response measured by MRD negativity after induction.[1]

Who the trials are for

The trials target narrow patient groups rather than the general public.[1]

  • Patients with cancer who are having total gastrectomy and risk of anastomosis dehiscence.[1]

  • Patients undergoing complex cardiac surgery with cardiopulmonary bypass and bleeding risk.[1]

  • People with ischemic stroke after rtPA who develop low fibrinogen levels.[1]

  • Thrombopenic patients with hematological malignancy after intensive chemotherapy who do not respond well to platelet transfusion.[1]

  • Adults with very high-risk T-lineage acute lymphoblastic leukemia receiving a multi-drug treatment program.[1]

Overall, the trial data show that Human Fibrinogen is being studied in settings where blood clotting support may matter most, especially around surgery and bleeding complications.[1]

Trial ID Phase Condition studied Status Enrollment
2024-519529-40-00 Phase 3 Esophagojejunal anastomosis dehiscence after total gastrectomy for cancer Authorised 240
NCT05091684 Phase 2 Bleeding in thrombopenic patients with hematological malignancy after intensive chemotherapy Completed 10
2024-512388-29-00 Phase 3 Bleeding in complex cardiac surgery with cardiopulmonary bypass Authorised 180
2024-516731-27-00 Phase 3 Ischemic stroke with secondary post-rtPA hypofibrinogenemia Authorised 200
NCT06253637 Phase 2 Very high-risk T-lineage acute lymphoblastic leukemia Authorised 31

FAQ

  • What is being studied in Human Fibrinogen trials? The trials are studying whether Human Fibrinogen can help control bleeding or reduce bleeding complications in selected patients. The main goals include checking efficacy and measuring outcomes such as transfusion needs, clotting results, and bleeding rates.
  • Who can take part in these studies? The target groups include people having complex cardiac surgery, patients with ischemic stroke after thrombolysis, thrombopenic patients with hematological malignancy, adults with very high-risk T-cell acute lymphoblastic leukemia, and patients having total gastrectomy for cancer. Each trial has its own entry rules.
  • What phases are the Human Fibrinogen trials in? The studies include Phase 2 and Phase 3 trials. Phase 2 trials focus more on early efficacy and biological effects, while Phase 3 trials look at stronger proof of benefit in larger groups.
  • What outcomes are measured in these trials? The trials measure bleeding-related outcomes such as dehiscence after surgery, blood product use, clot firmness and clot elasticity on ROTEM testing, intracranial hemorrhage, and effective hemostasis during surgery. Some trials also measure MRD negativity in leukemia.
  • Are all trials only about bleeding control? Most trials focus on bleeding or clotting problems, but one trial includes Human Fibrinogen as part of a treatment program for very high-risk T-cell acute lymphoblastic leukemia. That study measures treatment response rather than bleeding control alone.

Ongoing Clinical Trials on Human Fibrinogen

  • Study on Fibrinogen Concentrate (FGTW) for Managing Bleeding in Patients Undergoing Complex Cardiac Surgery

    Recruiting

    3 1 1
    Investigated drugs:
    Czechia Germany Italy Spain Sweden

  • Study on Fibrin Adhesive to Prevent Leaks After Stomach Cancer Surgery Using Aprotinin, Human Fibrinogen, and Calcium Chloride Dihydrate in Patients Undergoing Total Gastrectomy

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Fibrinogen Replacement to Prevent Brain Bleeding in Stroke Patients After Thrombolysis

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    Italy

  • Study for Adults with Very High-Risk T-Cell Acute Lymphoblastic Leukemia Using Daratumumab and a Drug Combination

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Italy

  • Study of Fibrinogen Treatment for Bleeding in Patients with Blood Cancer and Low Platelet Count Who Do Not Respond to Platelet Transfusions

    Not recruiting

    2 1 1 1
    Investigated drugs:
    France

  • Study on Andexanet Alfa for Patients on Factor Xa Inhibitors (Apixaban, Rivaroxaban, Edoxaban) Needing Urgent Surgery to Reduce Bleeding Risk

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Czechia Denmark Estonia +13

Glossary

  • Clinical trial: A research study in people that tests whether a treatment works and how safe or useful it is for a specific condition.
  • Interventional study: A study where researchers give a treatment or procedure and then measure the results.
  • Phase 2: An earlier trial phase that looks at how well a treatment works and gathers more safety or biological data.
  • Phase 3: A later trial phase that tests a treatment in larger groups to confirm benefit and compare it with standard care or placebo.
  • Enrollment: The number of people planned or included in a study.
  • Primary outcome: The main result the study is designed to measure.
  • Dehiscence: A surgical wound or join that opens or separates after surgery.
  • Hemostatic: Related to stopping bleeding and helping blood clot.
  • ROTEM: A blood test that checks how well blood clots and how strong the clot is.
  • Maximum clot firmness: A measure of how strong a blood clot becomes on testing.
  • Maximum clot elasticity: A clotting measure used to describe how the clot behaves and stretches during testing.
  • MRD negativity: Minimal residual disease is the small amount of cancer left after treatment; negativity means it was not found at the tested level.

References

  1. https://clinicaltrials.gov/study/2024-519529-40-00