In short
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.
Key points
- Clinical trials of Human Fibrinogen are mostly focused on bleeding control and clotting support in surgery, stroke after thrombolysis, and blood disorders. Several are Phase 3 studies, showing that researchers are testing it in larger patient groups. One Phase 2 study looks at clotting test changes in thrombopenic patients after chemotherapy, and another Phase 2 study includes Human Fibrinogen in treatment for very high-risk T-cell acute lymphoblastic leukemia. The main outcomes include bleeding rates, transfusion needs, clot strength, and surgical healing problems. The target populations are specific and include patients with cancer surgery, complex cardiac surgery, ischemic stroke after rtPA, and hematological disease.
Clinical trial overview
The source data includes interventional studies, which means the researchers give a treatment and then measure the results.
Most of the trials are in Phase 3, while two are in Phase 2.
The studies look at Human Fibrinogen in settings where bleeding, clotting problems, or blood product use are important outcomes.
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.
This study is randomized and multicenter, and it plans to enroll 240 people.
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.
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.
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.
This study plans to enroll 180 patients.
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.
The study aims to see whether fibrinogen infusion can reduce intracranial hemorrhage, which is bleeding inside the skull.
It also measures symptomatic intracranial hemorrhage using NINDS, ECASS, and SITS classifications, as well as extracerebral bleeding outside the brain.
The trial plans to enroll 200 patients.
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.
Thrombopenic means having a low platelet count, and platelets are blood cells that help stop bleeding.
The study tested fibrinogen together with platelet transfusion and used the ROTEM method to check clotting changes.
The main outcome was the change in maximum clot elasticity, which was derived from maximum clot firmness on the EXTEM curve.
The trial included 10 patients and focused on people with grade I or higher bleeding signs according to the WHO classification, modified by Slichter.
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.
This trial plans to enroll 31 patients.
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.
This is not a bleeding study only; it measures how well the leukemia treatment works in this high-risk group.
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.
In surgery studies, the key outcomes include dehiscence and the number of blood product units given after treatment.
In the stroke study, the main outcomes are intracranial hemorrhage, symptomatic intracranial hemorrhage, and extracerebral bleeding.
In the chemotherapy-related study, the focus is on ROTEM clotting measurements, especially maximum clot elasticity.
In the leukemia study, the endpoint is treatment response measured by MRD negativity after induction.
Who the trials are for
The trials target narrow patient groups rather than the general public.
- Patients with cancer who are having total gastrectomy and risk of anastomosis dehiscence.
- Patients undergoing complex cardiac surgery with cardiopulmonary bypass and bleeding risk.
- People with ischemic stroke after rtPA who develop low fibrinogen levels.
- Thrombopenic patients with hematological malignancy after intensive chemotherapy who do not respond well to platelet transfusion.
- Adults with very high-risk T-lineage acute lymphoblastic leukemia receiving a multi-drug treatment program.
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.