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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   44339   clinical trials with a EudraCT protocol, of which   7369   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 1 of 7.
    1  2  3  4  5  6  7  Next»
    EudraCT Number: 2010-018480-42 Sponsor Protocol Number: 550904 Start Date*: 2010-11-12
    Sponsor Name:Baxter Innovations GmbH
    Full Title: A RANDOMIZED, CONTROLLED, MULTICENTER PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FIBRIN SEALANT VH S/D 500 S-APR (TISSEEL) FOR HEMOSTASIS IN SUBJECTS UNDERGOING HEPATIC RESECTION
    Medical condition: Hemostasis in hepatic resection
    Disease: Version SOC Term Classification Code Term Level
    13.1 10042613 - Surgical and medical procedures 10060663 Surgical hemostasis LLT
    13.1 10042613 - Surgical and medical procedures 10067440 Hemostasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-000816-32 Sponsor Protocol Number: FC-005 Start Date*: 2014-10-17
    Sponsor Name:ProFibrix, A wholly owned subsidary of the Medicines Company
    Full Title: A Phase 3b, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Fibrocaps™ (Raplixa™) and Tachosil® in Surgical Hemostasis during Hepatic Resection
    Medical condition: Hepatic surgery specifically, hepatic wedge resection or anatomic resection of 1 to 5 contiguous hepatic segments, and/or other hepatic surgery, any of which may be combined with other surgical pro...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004865 10053001 Surgical haemostasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-003661-26 Sponsor Protocol Number: HX-02-PEP Start Date*: 2017-02-16
    Sponsor Name:Haemostatix Ltd
    Full Title: A controlled, randomized, multi-centre, double blind, phase II study to evaluate efficacy and safety of topical PeproStat in intraoperative surgical haemostasis
    Medical condition: To achieve haemostasis when bleeding cannot be controlled by conventional methods alone, such as manual pressure, cauterization, or sutures; or are inappropriate.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004865 10053001 Surgical haemostasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) PL (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2015-000091-10 Sponsor Protocol Number: 2014121566 Start Date*: Information not available in EudraCT
    Sponsor Name:Rigshospitalet, department of surgical Gastroenterology, C-Tx
    Full Title: RCT-comparison of two hemostatic devices (Hemopath vs. Tachosil) in liver resection.
    Medical condition: Bleeding during liver resection and the efficacy of 2 types of hemostatic patches on this, thus all diagnosis' that require liver resection.
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004865 10060663 Surgical hemostasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003408-21 Sponsor Protocol Number: THO-IM_02-CT Start Date*: 2015-12-09
    Sponsor Name:Thrombotargets Europe
    Full Title: A Phase II/III, randomized, controlled, single blind study to evaluate the haemostatic efficacy and safety of topically applied TT-173 in patients undergoing knee arthroplasty
    Medical condition: Haemostatic effect in patients undergoing knee arthroplasty
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004865 10060663 Surgical hemostasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-006174-47 Sponsor Protocol Number: FC-004 Start Date*: 2012-06-08
    Sponsor Name:ProFibrix BV
    Full Title: A Phase 3, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Haemostasis
    Medical condition: Intraoperative Surgical Hemostasis (Spinal Surgery, Vascular Surgery, Hepatic resection, Soft tissue dissection)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004865 10053001 Surgical haemostasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NL (Completed) GB (Completed)
    Trial results: Removed from public view
    EudraCT Number: 2013-003464-31 Sponsor Protocol Number: BIOS-13-004 Start Date*: 2014-02-21
    Sponsor Name:Ethicon Inc
    Full Title: A Single-blinded, Randomized, Controlled, Comparative Phase III Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Sur...
    Medical condition: subjects undergoing major aortic surgery, including ascending, arch, or descending aorta replacement, requiring adjunctive support for hemostasis at the anastomotic suture line
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2018-000434-34 Sponsor Protocol Number: HEM-01-17 Start Date*: 2020-06-18
    Sponsor Name:Sealantium Medical Ltd.
    Full Title: A Phase I/II, randomized, prospective, controlled, multi-center, open-label, two arm study evaluating the safety and preliminary efficacy of sFilm-FS in controlling liver bleeding during elective s...
    Medical condition: Open hepatic surgery, with presence of an target bleeding site (TBS).
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10067440 Hemostasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SI (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2012-002328-34 Sponsor Protocol Number: KB056 Start Date*: Information not available in EudraCT
    Sponsor Name:KEDRION S.P.A
    Full Title: Efficacy and safety evaluation of Kedrion Fibrin Sealant as an adjuvant for the control of hemostasis in pediatric patients undergoing abdominal or orthopedic surgery. Multicenter, randomized, cont...
    Medical condition: Paediatric patients undergoing abdominal or orthopedic surgery
    Disease: Version SOC Term Classification Code Term Level
    18.0 10042613 - Surgical and medical procedures 10067439 Haemostasis PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-005159-34 Sponsor Protocol Number: IG1103 Start Date*: 2014-06-16
    Sponsor Name:Instituto Grifols, S.A.
    Full Title: A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Soft Tissue Open Surgeries
    Medical condition: Treatment of haemorrhage resulting from soft tissue surgical procedure
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2013-002535-24 Sponsor Protocol Number: BIOS-13-005 Start Date*: 2013-09-20
    Sponsor Name:Ethicon Inc., a Johnson & Johnson Co.
    Full Title: A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST™ Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During 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:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-005127-16 Sponsor Protocol Number: IG1101 Start Date*: 2014-06-16
    Sponsor Name:Instituto Grifols, S.A.
    Full Title: A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis during Peripheral Vascular Surgery
    Medical condition: Treatment of haemorrhage resulting from a vascular surgical procedure
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2013-005128-40 Sponsor Protocol Number: IG1102 Start Date*: 2014-06-16
    Sponsor Name:Instituto Grifols, S.A.
    Full Title: A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Parenchymous Tissue Open Surge...
    Medical condition: Treatment of haemorrhage resulting from parenchymous tissue surgical procedure
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2019-004457-92 Sponsor Protocol Number: PB2452-PT-CL-0004 Start Date*: 2020-12-02
    Sponsor Name:SFJ Pharmaceuticals, Inc.
    Full Title: A Phase 3, Multicenter, Open-Label, Single-Arm Study of PB2452 in Ticagrelor-Treated Patients with Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure ...
    Medical condition: Uncontrolled Major or Life Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10053756 Invasive procedure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (GB - no longer in EU/EEA) BE (Completed) AT (Completed) NL (Completed) DE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-000072-25 Sponsor Protocol Number: IG402 Start Date*: 2008-08-04
    Sponsor Name:Instituto Grifols S.A.
    Full Title: Estudio prospectivo, simple ciego, de Fase II/III para evaluar la Seguridad y Eficacia del Adhesivo de Fibrina Grifols (FS Grifols) como un Adyuvante a la Hemostasia durante Cirugía Vascular Perifé...
    Medical condition: Adyuvante a la hemostasia en cirugía vascular periférica. Adjunct to hemostasis during peripheral vascular surgery.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-001610-14 Sponsor Protocol Number: 01072004 Start Date*: 2005-03-21
    Sponsor Name:Univ. hospital, Dpt. of anaesthesia
    Full Title: Effects of colloids on hemostasis in paediatric anaesthesia
    Medical condition: The aim of the study is to measure the effects of intraoperatively infused hydroxy-ethyl-starch and gelatin-solution on the coagulation system (fibrinpolymerisation and thrombingeneration) of infan...
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2016-004489-24 Sponsor Protocol Number: IG1405 Start Date*: 2018-09-13
    Sponsor Name:Instituto Grifols, S.A
    Full Title: A Prospective, Randomised, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis dur...
    Medical condition: Treatment of haemorrage during surgery
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BG (Completed) HU (Completed) DE (Completed) FR (Completed) SE (Prematurely Ended) GB (GB - no longer in EU/EEA) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2013-003401-26 Sponsor Protocol Number: 400-12-006 Start Date*: 2014-05-16
    Sponsor Name:Ethicon Inc.
    Full Title: A Prospective, Randomized, Controlled, Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Hemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non‐Cardiac) Surgery in Pediatric P...
    Medical condition: Abdominal, Retroperitoneal, Pelvic or Thoracic (Non‐Cardiac) Surgery
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2006-000028-15 Sponsor Protocol Number: TC-023-IM Start Date*: 2007-01-26
    Sponsor Name:Nycomed Danmark ApS
    Full Title: A randomised, open label, parallel-group, multi-centre trial to compare the efficacy and safety of TachoSil versus standard haemostatic treatment in the cardiovascular surgery
    Medical condition: Supportive haemostatic treatment in patients having elective surgery on the heart, the ascending aorta or arch, requiring pulmonary bypass procedure.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) DK (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-002620-17 Sponsor Protocol Number: 18-513 Start Date*: 2019-01-08
    Sponsor Name:Portola Pharmaceuticals, Inc
    Full Title: A PHASE 4 RANDOMIZED CLINICAL TRIAL OF ANDEXANET ALFA [ANDEXANET ALFA FOR INJECTION] IN ACUTE INTRACRANIAL HEMORRHAGE IN PATIENTS RECEIVING AN ORAL FACTOR XA INHIBITOR
    Medical condition: Oral FXa inhibitor-treated patients with acute intracranial 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 (Completed) DE (Completed) GB (GB - no longer in EU/EEA) AT (Completed) BE (Completed) NL (Completed) ES (Prematurely Ended) GR (Completed) CZ (Completed) LV (Completed) FI (Prematurely Ended) NO (Prematurely Ended) LT (Prematurely Ended) PL (Completed) PT (Prematurely Ended) DK (Prematurely Ended) IT (Prematurely Ended) HU (Prematurely Ended)
    Trial results: View results
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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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