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Adjusted Fibrinogen Replacement Strategy (AdFIrst)

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ClinicalTrials.gov Identifier: NCT03444324
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Biotest

Brief Summary:
The purpose of this study is to investigate efficacy and safety of fibrinogen concentrate BT524, when administered to patients with major blood loss during elective spine surgery.The study aims to demonstrate that BT524 is at least not worse than the comparator fresh frozen plasma in reducing intra-operative blood loss.

Condition or disease Intervention/treatment Phase
Bleeding Disorder Hypofibrinogenemia; Acquired Biological: BT524 Biological: FFP Phase 3

Detailed Description:
Fibrinogen is the first coagulation factor to become critically reduced during intra-operative bleeding. Therefore, rapid fibrinogen supplementation to restore physiological plasma levels is an important component to achieve and maintain hemostasis in bleeding patients. In this study, patients with major blood loss during elective spine surgery will be randomized 1:1 to a single intravenous transfusion of the fibrinogen concentrate BT524 or to fibrinogen-containing fresh frozen plasma (FFP).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomly assigned to treatment with BT524 or FFP.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Study 995 will be partially blinded; surgeon, surgical staff and subjects will be blinded to treatment allocation throughout the entire surgery. The IMP (BT524 or FFP) will be administered by an unblinded anaesthesiologist.
Primary Purpose: Treatment
Official Title: A Randomized, Active-controlled, Multicenter, Phase III Study Investigating Efficacy and Safety of Intra-operative Use of BT524 (Human Fibrinogen Concentrate) in Subjects Undergoing Major Spine Surgery
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

Arm Intervention/treatment
Experimental: BT524
Investigational Human Fibrinogen Concentrate
Biological: BT524
BT524 is administered intravenously, patient specific dosage calculated based on body weight and fibrinogen level.
Other Name: Human Fibrinogen concentrate

Active Comparator: Fresh Frozen Plasma (FFP)
Standard of Care
Biological: FFP
FFP is administered intravenously; dosage according to local standards in mL per kg body weight.
Other Name: Fresh Frozen Plasma




Primary Outcome Measures :
  1. Intra-operative blood loss [ Time Frame: Decision to treat until end of surgery, expected average of 3 hours ]
    Intra-operative blood loss as measured by amount of blood from blood suction unit and amount of blood from surgical cloths and compresses.


Secondary Outcome Measures :
  1. Correction of the fibrinogen level [ Time Frame: 15 minutes after start of IMP administration ]
    Proportion (%) of subjects with successful correction of fibrinogen level

  2. Transfusion requirements [ Time Frame: After end of IMP administration until end of surgery, expected average of 2 hours ]
    Total amount of transfusion products

  3. 24 hours post-operative blood loss [ Time Frame: 1 day after surgery ]
    Drainage volume

  4. Subjects with rebleeds [ Time Frame: 8 days after surgery ]
    Proportion (%) of subjects

  5. Hospital length of stay [ Time Frame: 35 days after surgery ]
    Days in hospital after surgery

  6. In-Hospital mortality [ Time Frame: 35 days after surgery ]
    Number of death during hospital stay

  7. Adverse events [ Time Frame: 35 days after surgery ]
    Number of adverse events

  8. Virus status [ Time Frame: 35 days after surgery ]
    Number of subjects with viral infection

  9. Thrombosis and of thromboembolic events [ Time Frame: 35 days after surgery ]
    Frequency and severity



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

At screening:

  1. Written informed consent
  2. Subjects scheduled for elective major spine surgery with expected major blood loss
  3. Male or female, aged ≥ 18 years
  4. No increased bleeding risk as assessed by standard coagulation tests and medical history

    Intra-operative:

  5. Intra-operative bleeding > 1,000 mL (total blood loss), resulting in a high risk for the need of FFP transfusion during surgery.

Exclusion Criteria:

  1. Pregnancy or unreliable contraceptive measures or lactation period (women only)
  2. Hypersensitivity to proteins of human origin or known hypersensitivity reactions to components of the Investigational Medicinal Products (IMP)
  3. Participation in another clinical study within 30 days before entering the study or during the study and/or previous participation in this study
  4. Treatment with any fibrinogen concentrate and/or fibrinogen-containing product within 30 days prior to infusion of BT524
  5. Employee or direct relative of an employee of the Contract Research Organization (CRO), the study site, or Biotest
  6. Inability or lacking motivation to participate in the study
  7. Medical condition, laboratory finding (e.g. clinically relevant biochemical or hematological findings outside the normal range), or physical exam finding that in the opinion of the investigator precludes participation
  8. Presence or history of venous/arterial thrombosis or TEE in the preceding 6 months -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444324


Contacts
Contact: Judith Wessels-Kranz, PhD 00496103801 ext 6395 judith.wessels-kranz@biotest.com
Contact: Joachim Schütze, PhD 00496103801 ext 5127 joachim.schuetze@biotest.com

Locations
Belgium
Site 02 Recruiting
Jette, Belgium
Site 01 Not yet recruiting
Leuven, Belgium
Germany
Site 11 Not yet recruiting
Bonn, Germany
Site 12 Not yet recruiting
Hannover, Germany
Site 14 Not yet recruiting
München, Germany
Site 13 Not yet recruiting
Münster, Germany
Poland
Site 22 Not yet recruiting
Grodzisk Mazowiecki, Poland
Site 21 Not yet recruiting
Warschau, Poland
Spain
Site 31 Recruiting
Barcelona, Spain
Site 32 Not yet recruiting
Barcelona, Spain
Site 33 Not yet recruiting
Barcelona, Spain
Switzerland
Site 42 Not yet recruiting
Lausanne, Switzerland
Site 41 Recruiting
Liestal, Switzerland
Sponsors and Collaborators
Biotest
PRA Health Sciences
Investigators
Principal Investigator: Niels Rahe-Meyer, Prof. Franziskus Hospital, Bielefeld

Responsible Party: Biotest
ClinicalTrials.gov Identifier: NCT03444324     History of Changes
Other Study ID Numbers: 995
2017‐001163‐20 ( EudraCT Number )
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biotest:
Fibrinogen

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders