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Clinical trials for Hemostasis

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44380   clinical trials with a EudraCT protocol, of which   7392   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    122 result(s) found for: Hemostasis. Displaying page 2 of 7.
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    EudraCT Number: 2006-000676-33 Sponsor Protocol Number: 292004 Start Date*: 2006-09-14
    Sponsor Name:NV Organon
    Full Title: A randomized, open-label, comparative, multi-center trial to evaluate the effects on hemostasis, lipids and carbohydrate metabolism, and on adrenal and thyroid function of a monophasic COC containi...
    Medical condition: Hormonal oral contraception in healthy women
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2021-004138-12 Sponsor Protocol Number: TAK-330-3001 Start Date*: 2022-04-11
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of PROTHROMPLEX TOTAL for the Rever...
    Medical condition: Patients on treatment with Factor Xa Inhibitor needing for an urgent intervention associated with a high risk of bleeding.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) BE (Trial now transitioned) AT (Trial now transitioned) NL (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-014420-37 Sponsor Protocol Number: PICCHE Start Date*: 2009-09-15
    Sponsor Name:AZIENDA OSPEDALIERA ISTITUTI CLINICI DI PERFEZIONAMENTO DI MILANO
    Full Title: PEDIATRIC INTENSIVE CARE C PROTEIN HEMOSTASIS STUDY
    Medical condition: SEVERE SEPSIS/ SEPTIC SHOCK
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-001583-36 Sponsor Protocol Number: AAG-G-H-0804 Start Date*: 2009-10-30
    Sponsor Name:Aesculap AG
    Full Title: Efficacy and Safety of Sangustop® as haemostatic agent versus a carrier-bound fibrin sealant during liver resection (ESSCALIVER)
    Medical condition: Male and female patients with indication for elective liver resection. The indication is to achieve haemostasis after liver resection.
    Disease: Version SOC Term Classification Code Term Level
    11.0 10062040 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2020-000374-21 Sponsor Protocol Number: 19-515 Start Date*: 2020-08-17
    Sponsor Name:Alexion Pharmaceuticals, Inc
    Full Title: PROSPECTIVE, OPEN-LABEL STUDY OF ANDEXANET ALFA IN PATIENTS RECEIVING A FACTOR XA INHIBITOR WHO REQUIRE URGENT SURGERY (ANNEXA-S)
    Medical condition: Need for FXa inhibitor reversal in patients undergoing urgent surgery.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2010-019427-58 Sponsor Protocol Number: 400-10-001 Start Date*: 2010-09-08
    Sponsor Name:Omrix Biopharmaceuticals Ltd
    Full Title: A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
    Medical condition: Subjects undergoing elective, open, hepatic surgery during which a resection plane is created and wherein an appropriate Target Bleeding Site is identified.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10068093 Gastrointestinal surgery LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2005-001579-37 Sponsor Protocol Number: 3082B2-311-WW Start Date*: 2006-02-16
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals, Inc. Clinical Research and Development
    Full Title: An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
    Medical condition: Male subjects with hemophilia A (FVIII:C ≤2% confirmed at screening), previously treated with ≥ 150 exposure days to any Factor VIII product, undergoing elective major surgery that is anticipated t...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: SE (Prematurely Ended) AT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-003371-18 Sponsor Protocol Number: MAA-202 Start Date*: 2021-03-30
    Sponsor Name:Catalyst Biosciences, Inc.
    Full Title: Phase 1/2 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Marzeptacog alfa (activated) in Treatment of Episodic Bleeding in Subjects with Inherited Bleeding Disorders
    Medical condition: Factor VII deficiency, Glanzmann thrombasthenia (GT) and Hemophilia A with inhibitors on emicizumab prophylaxis (HAwI-E)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10016079 Factor VII deficiency PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-004835-39 Sponsor Protocol Number: 400-08-002 Start Date*: 2008-11-13
    Sponsor Name:OMRIX biopharmaceuticals Ltd
    Full Title: A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Severe Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvi...
    Medical condition: Patients undergoing abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-002998-11 Sponsor Protocol Number: ENDO-RCA Start Date*: 2014-11-14
    Sponsor Name:Rigshospitalet, Capital Region Bloodbank 2034, Section for Transfusion Medicine
    Full Title: Safety and efficacy of low-dose Iloprost administration and blood pressure target in addition to standard therapy, as compared to standard therapy alone, in post-cardiac- arrest-syndrome patients...
    Medical condition: Cardiac Arrest
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004849 10007517 Cardiac arrest transient LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2006-005454-76 Sponsor Protocol Number: GAS-04-04 Start Date*: 2004-10-01
    Sponsor Name:IRCCS CASA SOLLIEVO DELLA SOFFERENZA
    Full Title: PPI as an adjunct to endoscopic hemostasis for bleeding peptic ulcer a randomized clinical trial of a high vs a standard regimen for the i.v. drug infusion
    Medical condition: Patients with peptic ulcer bleeding
    Disease: Version SOC Term Classification Code Term Level
    8.1 10034344 Peptic ulcer haemorrhage LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-000909-24 Sponsor Protocol Number: 201302-OPTICLOT Start Date*: 2013-08-29
    Sponsor Name:Erasmus MC
    Full Title: "OPTI-CLOT": Peri-Operative PharmacokineTIc-guided dosing of CLOTting factor in Hemophilia.
    Medical condition: Hemophillia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10066439 Hemophilia LLT
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-001425-26 Sponsor Protocol Number: REDOX19032019 Start Date*: 2019-07-04
    Sponsor Name:Thoraxcentrum Erasmus MC
    Full Title: Rotterdam Edoxaban Leaflet Evaluation in Patients after Transcatheter Aortic Valve Implantation
    Medical condition: aortic stenosis
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005788-34 Sponsor Protocol Number: NL79578.100.21 Start Date*: 2022-03-31
    Sponsor Name:St. Antonius Hospital
    Full Title: Platelet inhibition versus direct oral anticoagulation in patients undergoing percutaneous closure of patent foramen ovale or atrial septal defect
    Medical condition: Atrial septal defect or patent foramen ovale indicated for percutaneous closure with an occluder device.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-011603-23 Sponsor Protocol Number: KB048 Start Date*: 2009-09-11
    Sponsor Name:KEDRION
    Full Title: Evaluation of Haemostatic Efficacy, Tolerability and Safety of Kedrion Fibrin Sealant in patients undergoing major or minor Liver Surgery. Multicenter, Controlled, Open Label Randomised Phase II/...
    Medical condition: Epatic resection (minor or major)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-018086-12 Sponsor Protocol Number: BI1412_2009 Start Date*: 2010-08-23
    Sponsor Name:Athena Care/ Isala Klinieken
    Full Title: Efficacy and safety of Haemocomplettan® P in patients experiencing microvascular bleeding while undergoing elective complex cardiac surgery
    Medical condition: Elective complex cardiac surgery is associated with excessive blood loss due to coagulopathy. Fibrinogen concentrate has been shown to reverse dilutional coagulopathy. In this double blinded, place...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10009802 Coagulopathy LLT
    12.1 10000531 Acquired afibrinogenaemia LLT
    12.1 10005517 Blood fibrinogen LLT
    12.1 10011976 Decreased plasma fibrinogen LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-000177-39 Sponsor Protocol Number: Linea7-2013/06-APPEAR Start Date*: 2014-07-17
    Sponsor Name:IRCCS Policlinico San Donato
    Full Title: Albumin vs. Plasma for PEdiAtric pRiming (APPEAR) trial
    Medical condition: Congenital cardiac diseases needing surgical correction requiring intervention with extracorporeal circulation
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-020202-16 Sponsor Protocol Number: FC-002 Start Date*: 2010-11-19
    Sponsor Name:ProFibrix BV
    Full Title: A Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety and Study of Topical Fibrocaps™ and Gelatin Sponge (USP) in Surgical Hemostasis in the Netherlands
    Medical condition: Hepatic resection or soft tissue dissection
    Disease: Version SOC Term Classification Code Term Level
    12.1 10042609 Surgery LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: Removed from public view
    EudraCT Number: 2008-001872-54 Sponsor Protocol Number: ARC1779−006 Start Date*: 2009-01-24
    Sponsor Name:Archemix Corp
    Full Title: A Randomized, Double−blind, Placebo−controlled, Clinical Outcome Study of ARC1779 Injection in Patients with Thrombotic Microangiopathy.
    Medical condition: Thrombotic microangiopathy (TMA) disorders
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009731 Coagulation disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) AT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-003359-12 Sponsor Protocol Number: CCH2012-02 Start Date*: 2015-02-18
    Sponsor Name:VU University Medical Center
    Full Title: The effect of a high and low protamine-to-heparin dosing on perioperative hemostasis: a randomized clinical trial.
    Medical condition: Patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004865 10006894 CABG LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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