Thrombosis – Trials in Disease

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Ongoing Clinical Trials for Thrombosis

There are currently 4 clinical trials investigating different approaches to preventing and managing blood clots (thrombosis) in various patient populations. These studies are taking place across Europe, including France, Spain, Finland, and Greece, and are testing medications such as rivaroxaban, apixaban, tinzaparin sodium, and enoxaparin sodium in patients with conditions ranging from lower limb injuries to pancreatic cancer.

Clinical trial locations

Study Comparing Rivaroxaban and Drug Combination for Preventing Blood Clots in Patients with Lower Limb Injuries Requiring Immobilization

This trial is taking place in France and focuses on patients who have suffered a lower limb injury requiring immobilization with a brace or cast. The study compares two different approaches to preventing dangerous blood clots during the healing period.

Who can participate: Adults aged 18 years or older who have visited the emergency department with a lower limb injury needing rigid or semi-rigid support for at least 2 weeks are eligible. Participants must have a TRiP(cast) score of 7 or higher, which indicates an increased risk of developing blood clots. The hospital stay should be planned for 72 hours or less, and participants must provide informed consent.

Who cannot participate: The trial excludes patients whose injuries do not require immobilization, those with a risk score below 7, individuals outside the specified age range, and members of vulnerable populations requiring special protection.

What the trial is testing: The study compares rivaroxaban, taken as an oral tablet, with low-molecular weight heparin (LMWH), given as injections under the skin. Both treatments aim to prevent blood clots from forming during the immobilization period. The main goal is to determine whether rivaroxaban is as effective as LMWH in preventing serious complications like deep vein thrombosis or pulmonary embolism within 45 days after starting treatment.

Investigational drugs: Rivaroxaban works by blocking a specific protein in the blood called Factor Xa, which plays a key role in clot formation. LMWH serves as the standard comparison treatment, commonly used in patients at high risk of developing clots due to reduced mobility.

Study on Short-term Interruption vs. Continuous Anticoagulation with Apixaban in Patients Undergoing Colorectal Polypectomy

This Spanish trial addresses an important question for patients taking blood thinners who need to have polyps removed from their colon during a colonoscopy procedure.

Who can participate: Adults aged 18 years or older who are scheduled for an elective outpatient colonoscopy and are already taking anticoagulant medications are eligible. The medications include vitamin K antagonists like acenocoumarol or warfarin, or direct oral anticoagulants such as dabigatran, edoxaban, apixaban, or rivaroxaban.

Who cannot participate: The study excludes patients not receiving oral anticoagulant therapy, those not scheduled for an elective colonoscopy, individuals under 18 or over 65 years of age, and members of vulnerable populations.

What the trial is testing: The study investigates whether it is safe to continue taking blood thinning medications during polyp removal or whether a short-term interruption is necessary. Researchers will monitor participants for bleeding complications and blood clotting events after the procedure to determine which approach is safer.

Investigational drugs: The trial examines various anticoagulants including apixaban, acenocoumarol, dabigatran etexilate, warfarin, rivaroxaban, and edoxaban. These medications work by preventing blood clots through different mechanisms, and the study aims to establish the best management strategy during colonoscopy procedures.

Study on Preventing Blood Clots in Pancreatic Cancer Patients Using Tinzaparin Sodium and Enoxaparin Sodium During Treatment

This Finnish trial focuses on pancreatic cancer patients receiving treatment before surgery, known as neoadjuvant therapy. Cancer patients face an increased risk of developing blood clots, and this study explores ways to prevent this complication.

Who can participate: Adult patients with pancreatic cancer who are planning to receive neoadjuvant treatments before their main cancer therapy are eligible. Both men and women can participate in the study.

Who cannot participate: Patients not receiving neoadjuvant treatments, those not at increased risk of blood clots, individuals unsuitable for preventive blood clot treatment, those outside the specified age range, and members of vulnerable populations cannot participate.

What the trial is testing: The study examines whether using tinzaparin sodium or enoxaparin sodium during neoadjuvant treatment can reduce the risk of blood clots and potentially improve overall survival and quality of life. Participants receive injections under the skin throughout their treatment period, with regular blood samples collected to monitor clotting activity. The study will follow patients for at least five years.

Investigational drugs: Both tinzaparin sodium and enoxaparin sodium are types of low molecular weight heparin, classified as anticoagulants. They work by inhibiting the formation of blood clots, which is particularly important in cancer patients undergoing intensive treatment.

Study on the Effect of Tinzaparin Sodium on Survival in Patients with Advanced Pancreatic Cancer

This Greek trial investigates whether adding blood clot prevention therapy to standard chemotherapy can improve outcomes for patients with advanced pancreatic cancer.

Who can participate: Adults aged 18 years or older with locally advanced or metastatic pancreatic cancer confirmed by appropriate tests are eligible. Participants must be planning to start first-line chemotherapy with nab-paclitaxel (NabG), have an ECOG performance score of 0-2 indicating reasonable daily functioning, have a life expectancy of more than 6 months, and provide written informed consent.

Who cannot participate: The study excludes patients not receiving treatment for advanced pancreatic cancer, those not undergoing chemotherapy with NabG, individuals not eligible for blood clot prevention, patients unable to receive tinzaparin, those outside the specified age range, and members of vulnerable populations.

What the trial is testing: The study evaluates whether adding tinzaparin sodium to standard chemotherapy can improve progression-free survival, meaning the time patients live without their cancer worsening. Tinzaparin is given as injections under the skin alongside chemotherapy. Researchers will monitor for blood clot events, bleeding complications, overall response to treatment, quality of life changes, and overall survival.

Investigational drugs: Tinzaparin sodium is a low molecular weight heparin that prevents blood clots by inhibiting key clotting factors in the blood. Nab-paclitaxel is a chemotherapy drug that works by stopping cancer cell growth. The combination aims to both treat the cancer and reduce the risk of potentially life-threatening blood clots.

Summary

These four clinical trials represent diverse approaches to managing and preventing blood clots in different patient populations. Two trials focus specifically on pancreatic cancer patients in Finland and Greece, examining whether blood clot prevention can improve outcomes during cancer treatment. The French trial addresses blood clot prevention in patients with lower limb injuries requiring immobilization, while the Spanish study tackles the practical question of managing blood thinning medications during colonoscopy procedures.

A notable pattern is the use of low molecular weight heparins, particularly tinzaparin sodium, in multiple trials, suggesting continued interest in this class of medications for blood clot prevention. The trials also reflect a geographical concentration in Southern and Northern Europe, with each country represented by a single study addressing distinct clinical scenarios. These studies collectively aim to refine treatment strategies for preventing thrombosis while minimizing bleeding risks across different medical situations.

Ongoing Clinical Trials on Thrombosis

  • Study on the Effect of Tinzaparin Sodium on Survival in Patients with Advanced Pancreatic Cancer

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Greece
  • A study to compare the absorption of apixaban capsules and apixaban tablets in healthy volunteers to prevent thrombosis.

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain