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Desmopressin and FVIII concentrate combination treatment in non-severe hemophilia A patients undergoing minor interventions

To show a reduction in FVIII-concentrate consumption with perioperative desmopressin and FVIII concentrate combination treatment compared to FVIII concentrate monotherapy, without decreasing the effectivity of treatment.

He-move-philia, a combined lifestyle intervention program for patients with hemophilia and other congenital coagulation disorders

The aim of this exploratory study is to compare the effect of a lifestyle intervention program consisting of combined individual coaching and group sessions (CLI) with a lifestyle intervention program with individual coaching only (II).The program…

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of Ravulizumab in Adult and Adolescent Participants who have Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplant (HSCT)

This study has been transitioned to CTIS with ID 2023-510107-22-00 check the CTIS register for the current data. To assess the efficacy of ravulizumab versus placebo in the treatment of adult and adolescent participants with HSCT-TMA.

WATCHMAN FLX versus NOAC for EMbolic ProtectION in the
management of patients with Non-Valvular Atrial Fibrillation
(CHAMPION-AF) S2437

The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonablealternative to non-vitamin K oral anticoagulants (NOACs) in patients with non-valvular atrial fibrillation.

Tranexamic acid during excisional burn surgery

This study has been transitioned to CTIS with ID 2024-513573-49-00 check the CTIS register for the current data. The objectives of this study are twofold, (1) to investigate whether tranexamic acid reduces the volume of blood loss and number of…

Heavy menstrual bleeding in premenopausal women treated with direct oral anticoagulants - a randomised controlled trial.

To evaluate management strategies in premenopausal women with heavy menstrual bleeding associated with factor Xa inhibitor therapy.

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated With a Trigger

PrimaryTo assess the efficacy of ravulizumab in the treatment of participants with TMASecondaryTo characterize TMA responseTo assess impact on hemoglobin levels To evaluate change in kidney function To assess duration of Complete TMA Response and…

Peroperative Administration of Tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce hemorrhage rates (PATRY study): a randomized controlled trial

This study has been transitioned to CTIS with ID 2024-513570-22-00 check the CTIS register for the current data. This trial aims to investigate whether peroperative administration of TXA reduces haemorrhage rates in patients who undergo metabolic…

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacodynamics of Intravenously Administered Prothrombin Complex Concentrate (PCC) in Combination with a Selected FXa Direct Oral Anticoagulant (FXa DOAC) in Healthy Subjects.

Primary objective:• To assess, in healthy subjects, the pharmacodynamic (PD) properties of PCC in the presence and absence of selected DOACs.Secondary objectives:• To assess, in healthy subjects, the safety and tolerability of PCC in the presence…

Validation TAP-100 blood collection device

Before routinely starting collection of blood with these devices several objectives need to be addressed. A) Is there a difference in coagulation activation parameters between blood collected by venous phlebotomy, finger prick capillary blood and…

Peroperative Administration of Tranexamic Acid in Sleeve gastrectomy (PATAS) to reduce hemorrhage rates

This trial aims to investigate if peroperative administration of TA can reduce the peroperative and postoperative hemorrhage rates in laparoscopic sleeve gastrectomy.

What is the optimal antithrombotic strategy in patients presenting with acute coronary syndrome having atrial fibrillation with indication for anticoagulants?

1. To investigate the efficacy of dual therapy (omitting acetylsalicylic acid) compared to triple therapy in patients with atrial fibrillation and acute coronary syndrome.2. To investigate the safety of dual therapy (omitting acetylsalicylic acid)…

Long-term treatment of cancer associated venous thromboembolism: reduced vs full dose of apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis

ThThe primary efficacy objective is to determine whether a low-dose regimen of apixaban (2.5 mg bid) is non-inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent VTE in patients with cancer who have completed at…

Randomized placebo-controlled pilot study to determine the effect of probiotics on vitamin K status in renal transplant recipients

To investigate the effect of a daily sachet of probiotics for 12 weeks vs placebo on vitamin K status in renal transplant recipients.

A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients with Hemophilia A or B, with Inhibitory Antibodies to Factor VIII or IX

1.3. Study Design Rationale The ATLAS-INH trial (ALN-AT3SC-003) is a multicenter, multinational, randomized, openlabel Phase 3 study designed to demonstrate the efficacy and safety of fitusiran in patients with haemophilia A or B with inhibitory…

Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism

The primary efficacy objective is to assess the incidence of symptomatic recurrent venous thromboembolism.The secondary efficacy objective is to assess the incidence of symptomatic recurrent venous thromboembolism and asymptomatic deterioration on…

A Phase 3, open-label, randomized, multi-center, controlled trial to evaluate the pharmacokinetics and pharmacodynamics of edoxaban and to compare the efficacy and safety of edoxaban with standard of care anticoagulant therapy in pediatric subjects from birth to less than 18 years of age with confirmed venous thromboembolism (VTE)

The primary objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), or vitamin K antagonist (VKA)) in the treatment and secondary prevention of VTE in pediatric subjects…

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ISIS 416858 (IONIS-FXIRX an Antisense Inhibitor of Factor XI), Administered Subcutaneously to Patients with End-Stage Renal Disease on Hemodialysis

Primary objectives: To evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ISIS 416858 (200, 250, and 300 mg once weekly) as compared to placebo.Exploratory Objectives: Incidence of myocardial infarction (MI), stroke, systemic…

More precise dosing of acenocoumarol in patients aged 80 and above, a pilot study

The main objective is to collect data on effect size for, and determine the feasibility of, a full scale RCT to assess the effect of dosing per 0.5 mg acenocoumarol on quality of anticoagulation, treatment satisfaction, and medication errors.