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Completed

NCT Number: NCT00977925

The Severe Soft Tissue Bleeding Study

The objective of this study is to evaluate the safety and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.

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Key information

Conditions

Soft Tissue Bleeding

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bankstown Hospital, Bankstown, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects >= 18 years of age, requiring elective, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures;
  • Presence of an appropriate severe bleeding soft tissue Target Bleeding Site (TBS) as identified intra-operatively by the surgeon;
  • Subjects must be willing to participate in the study, and provide written informed consent.

Exclusion criteria

  • Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
  • Bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of the FP to blood flow and pressure during healing and absorption of the product;
  • Subject with TBS within an actively infected field;
  • Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
  • Subjects with known intolerance to blood products or to one of the components of the study product;
  • Subjects unwilling to receive blood products;
  • Subjects with known immunodeficiency diseases (including known HIV);
  • Subjects who are known, current alcohol and / or drug abusers;
  • Subjects who have participated in another investigational drug or device research study within 30 days of enrollment;
  • Female subjects who are pregnant or nursing.

Treatment and study plan

Fibrin Pad

Biological

Fibrin Pad is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).

Standard of care

Procedure

Standard of Care is a composite of techniques/methods typically used by the surgeon to control severe bleeding.

Primary outcomes

  1. Proportion of subjects achieving hemostasis at the Target Bleeding Site. Hemostasis is defined as no detectable bleeding at the TBS.

    Time frame: Intra-operative

Secondary outcomes

  1. Proportion of subjects achieving hemostatic success at 10 minutes following randomization

    Time frame: Intra-operative

  2. Absolute time to hemostasis

    Time frame: Intra-operative

  3. Proportion of subjects requiring re-treatment at the TBS prior to wound closure

    Time frame: Intra-operative

  4. Incidence of treatment failures

    Time frame: Intra-operative

  5. Incidence of adverse events that are potentially related to bleeding at the TBS

    Time frame: Intra-operative through 60 days

  6. Incidence of adverse events that are potentially related to thrombotic events;

    Time frame: Intra-operative through 60 days

  7. Incidence of adverse events

    Time frame: Intra-operative through 60 days

Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Registry information

Official study 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, Pelvic, and Thoracic Surgery

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 16, 2009
Registry last updated
Oct 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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