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Ongoing Clinical Trials for Coagulopathy

There are currently 5 clinical trials investigating treatments for coagulopathy and related blood clotting disorders. These studies are taking place across Europe and focus on conditions ranging from bleeding complications in patients taking blood thinners to blood clotting problems in children undergoing heart surgery or stem cell transplants.

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Study of Narsoplimab for Children with High-Risk Blood Vessel Damage After Stem Cell Transplant

This trial is investigating Narsoplimab as a treatment for children who develop a serious complication after stem cell transplant called Haematopoietic Stem Cell Transplant Thrombotic Microangiopathy. This condition causes damage to small blood vessels, leading to low platelet counts and other health problems.

Main inclusion criteria: Children must be between 28 days and 18 years old and have received an allogeneic stem cell transplant for either cancerous or non-cancerous disease. They must have a confirmed diagnosis of high-risk HSCT-TMA, which includes having low platelet counts (less than 50,000 per microliter) or a significant drop in platelets, along with signs of red blood cell destruction. High-risk features may include persistent HSCT-TMA lasting 2 weeks or more, abnormal kidney function, evidence of TMA in the digestive system, nervous system problems, fluid around the heart or lungs, or high blood levels of a specific substance called C5b-9.

Main exclusion criteria: Children who have had a stem cell transplant but do not have thrombotic microangiopathy cannot participate. Those who are not considered high-risk, are outside the specified age range, or do not meet the clinical trial group requirements are also excluded.

Focus and goal: The study aims to evaluate whether Narsoplimab can improve survival rates and overall health in children with high-risk HSCT-TMA. Researchers will monitor participants over time to assess survival 100 days after diagnosis, as well as longer-term health outcomes. They will also examine how the body processes the medication and any potential side effects.

Investigational drug: Narsoplimab is a monoclonal antibody that is given by intravenous injection. It works by blocking a protein called MASP-2, which is involved in the immune system’s complement pathway, thereby reducing inflammation and blood vessel damage.

Study on TAK-330 for Reversing Anticoagulation in Patients on Factor Xa Inhibitors Needing Urgent Surgery

This trial focuses on adults taking blood-thinning medications called Factor Xa inhibitors who need urgent surgery or procedures with high bleeding risk. The study is testing whether TAK-330 can effectively reverse the blood-thinning effects to make surgery safer.

Main inclusion criteria: Patients must be at least 18 years old and currently taking a Factor Xa inhibitor such as rivaroxaban, apixaban, or edoxaban. The surgeon must determine that urgent surgery or a procedure with high bleeding risk is needed within 15 hours of the last dose of the blood thinner. If more than 15 hours have passed, blood tests must show high levels of the medication. Women of childbearing potential must have a negative pregnancy test.

Main exclusion criteria: Patients who are not taking a Factor Xa inhibitor, do not need urgent surgery with high bleeding risk, or do not have evidence of the medication in their blood at appropriate levels cannot participate.

Focus and goal: The study compares TAK-330 to the standard treatment (4F-PCC) to see which is more effective at reversing the blood-thinning effects. Researchers will monitor the occurrence of effective blood clotting during and after surgery, as well as any complications or side effects that may occur.

Investigational drug: TAK-330 is a solution containing several human clotting proteins (Factor IX, Protein C, Factor VII, Factor II, and Factor X) that is given by intravenous injection. It is designed to counteract the effects of Factor Xa inhibitors and restore normal blood clotting.

Study on the Effectiveness of Human Coagulation Factor IX and Drug Combination for Patients with Major Bleeding on Factor Xa Inhibitor Therapy

This study examines patients experiencing serious bleeding while taking direct oral anticoagulants that inhibit Factor Xa. It tests OCTAPLEX, a four-factor prothrombin complex concentrate, to see if it can effectively stop major bleeding.

Main inclusion criteria: Patients must be at least 18 years old and currently taking a Factor Xa inhibitor (rivaroxaban, apixaban, or edoxaban). They must have anti-factor Xa activity levels of at least 100 ng/mL and be experiencing acute major bleeding, which includes life-threatening bleeding in critical areas like the brain, spine, eyes, stomach, or muscles, or a significant drop in hemoglobin levels.

Main exclusion criteria: Patients not experiencing acute major bleeding, not taking Factor Xa inhibitor therapy, outside the specified age range, or not meeting the clinical trial group criteria are excluded.

Focus and goal: The trial evaluates different doses of OCTAPLEX to determine which is more effective in managing major bleeding. Researchers monitor patients for 48 hours after treatment to assess the medication’s ability to control bleeding and watch for any side effects or complications.

Investigational drug: OCTAPLEX is a prothrombin complex concentrate containing four clotting factors. It is administered intravenously and works by supplying the body with clotting factors that are reduced by Factor Xa inhibitors, thereby restoring the blood’s ability to clot.

Evaluation of Enoxaparin for Prevention of Localized Intravascular Coagulopathy in Children with Slow-Flow Vascular Malformations Undergoing Interventional Procedures

This trial studies whether enoxaparin, a blood-thinning medication, can prevent abnormal blood clotting in children with slow-flow vascular malformations who are undergoing procedures like sclerotherapy, cryoablation, or electroporation.

Main inclusion criteria: Children must be between 0 and 18 years old and have a venous malformation or low-flow venous/lymphatic malformation. They must be scheduled for a minimally invasive procedure such as sclerotherapy, cryoablation, or electroporation. Parents or legal guardians must provide informed consent, and children aged 12 or older must also agree to participate.

Main exclusion criteria: Children without the specific types of vascular malformations, not scheduled for the specified procedures, with allergies to enoxaparin, active major bleeding or high risk of uncontrolled bleeding, severe kidney problems, currently taking other blood thinners that cannot be stopped, or who are pregnant or breastfeeding cannot participate.

Focus and goal: The study aims to determine if enoxaparin can safely and effectively prevent localized intravascular coagulopathy when given before procedures. Researchers will measure blood clotting factors before and after procedures and monitor for bleeding complications, pain, inflammation, and other outcomes.

Investigational drug: Enoxaparin is a low molecular weight heparin given by injection under the skin. It works by interfering with the blood’s clotting process to prevent the formation of blood clots within the vascular malformation during treatment procedures.

Study on Coagulation Differences Using Fresh Frozen Plasma and Solvent-Detergent Plasma in Children Undergoing Congenital Heart Surgery

This trial compares two types of plasma used to support blood clotting in children undergoing heart surgery: fresh frozen plasma and Solvent-detergent plasma (Omniplasma). The goal is to determine which type better supports healthy blood clotting.

Main inclusion criteria: Children must be undergoing cardiac surgery that requires the use of a heart-lung machine (cardiopulmonary bypass). Participants are either children under 1 year old or those undergoing specific surgeries called Glenn or Fontan procedures. Parents or guardians must provide informed consent.

Main exclusion criteria: Children not undergoing pediatric cardiac surgery, outside the specified age range, with medical conditions that might interfere with study results, who have recently participated in another clinical trial, with allergies to substances used in the study, with bleeding disorders, taking medications that interfere with blood clotting, or with serious health conditions affecting participation are excluded.

Focus and goal: The study measures differences in blood clotting factors after surgery between children who receive fresh frozen plasma and those who receive Omniplasma. Key measurements include protein S activity, α2-antiplasmin, and other clotting factors. This information will help doctors understand which type of plasma might provide better support during pediatric heart surgery.

Investigational products: Fresh frozen plasma is a blood product made from the liquid part of whole blood, containing important clotting proteins. Omniplasma is plasma treated with a solvent-detergent process to reduce infection risk. Both are given intravenously and contain proteins crucial for blood clotting.

Summary

The five ongoing clinical trials for coagulopathy-related conditions show a diverse range of research focuses across Europe. A notable concentration of trials is taking place in Germany, Spain, and the Netherlands, which appear in multiple studies. The trials address different patient populations, from pediatric patients undergoing stem cell transplants or heart surgery to adults needing urgent surgical procedures while on blood thinners.

Several studies focus on managing bleeding complications in patients taking Factor Xa inhibitors, highlighting the clinical importance of safely reversing these medications in emergency situations. Two trials specifically test reversal agents (TAK-330 and OCTAPLEX) for this indication, reflecting ongoing efforts to improve emergency care for patients on modern blood thinners.

Pediatric populations are well represented, with three trials focusing exclusively on children. These address complications after stem cell transplant, prevention of clotting during vascular malformation procedures, and optimization of plasma use during heart surgery. The variety of conditions and treatments being studied demonstrates the complexity of blood clotting disorders and the ongoing need for better treatment options across different patient groups and clinical scenarios.

Ongoing Clinical Trials on Coagulopathy

  • Study on Coagulation Differences Using Fresh Frozen Plasma and Solvent-Detergent Plasma in Children Undergoing Congenital Heart Surgery

    Not yet recruiting

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    The Netherlands

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