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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02014402
Other study ID # IG1202 (IG1202-A, -B, -C, -D)
Secondary ID
Status Completed
Phase Phase 2
First received December 12, 2013
Last updated April 14, 2016
Start date December 2013
Est. completion date November 2015

Study information

Verified date April 2016
Source Grifols Biologicals Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This purpose of this clinical trial is to study the safety and efficacy of Topical Thrombin (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft tissue, and spinal open surgical procedures. Approximately 180 subjects will be treated with either Topical Thrombin (Human) Grifols (120 subjects) or Bovine Thrombin JMI® (60 subjects). Subjects will be evaluated for identification of a target bleeding site (TBS) in which control of bleeding by standard surgical techniques is ineffective or impractical and requires an additional treatment to stop the bleeding. The Investigator (surgeon) will rate the intensity of bleeding at the TBS. Topical Thrombin (Human) Grifols or Bovine Thrombin JMI will then be applied to the TBS and the amount of bleeding at the TBS will be examined.


Description:

This is a prospective, randomized, double-blind, controlled, Phase II study to evaluate the safety and efficacy of Topical Thrombin (Human) Grifols as an adjunct to hemostasis during vascular (IG1202-A), hepatic (IG1202-B), soft tissue (IG1202-C), and spinal (IG1202-D) open surgical procedures. Approximately 180 subjects will be randomized into 1 of 2 treatment groups in a 2:1 ratio: Topical Thrombin (Human) Grifols (120 subjects) or Bovine Thrombin JMI (60 subjects) among the 4 types of surgeries. Randomized subjects will be evaluated for identification of a target bleeding site (TBS) in which control of bleeding by conventional surgical techniques (including suture, ligature and cautery) is ineffective or impractical and requires an adjunct treatment to achieve hemostasis. The Investigator will rate the intensity of bleeding at the TBS. Topical Thrombin (Human) Grifols or Bovine Thrombin JMI will be applied to the TBS and hemostasis will be assessed at various timepoints during a 5-minute observation period.


Recruitment information / eligibility

Status Completed
Enrollment 181
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Pre-operative (at Baseline Assessments Visit) hemoglobin (Hgb) =9.0 g/dL (deciliter)

- Pre-operative (at Baseline Assessments Visit) fibrinogen level =150 mg/dL (functional method).

- Require one of the following procedures:

1. An elective (non-emergency), open (non-laparoscopic; non- endovascular) surgical procedure involving a native artery-graft end-to-side proximal anastomosis utilizing coated or uncoated polytetrafluoroethylene (PTFE) graft (IG1202-A).

2. An elective (non-emergency), open (non-laparoscopic) hepatic resection (anatomic and non-anatomic resections of at least one anatomical hepatic segment or equivalent tissue volume) (IG-1202-B).

3. An elective (non-emergency), open (non-laparoscopic), surgical procedure involving soft (non-parenchymous) tissue (IG1202-C).

4. An elective (non-emergency), spinal surgical procedure in which the epidural venous plexus should be exposed (IG1202-D).

- A target bleeding site (TBS) can be identified according to the Investigator's judgment, and the TBS has mild or moderate bleeding according to the Investigator's judgment.

Exclusion Criteria:

- Requires surgical procedure due to trauma (except for spinal surgery).

- Infection in the anatomic surgical area.

- History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived (human or animal) product.

- Previous known sensitivity to any Topical Thrombin (Human) Grifols component, any Bovine Thrombin JMI component, porcine collagen, and heparin or protamine (vascular surgery only) component.

- Receiving an organ transplant.

- Undergoing another concurrent major surgical intervention beyond the liver (applies to hepatic surgery [IG1202-B] only; concurrent interventions on the pancreas, gall bladder, bile duct, or intestines are allowed).

- Undergoing a re-operative procedure, which is defined as a second, or successive, surgical procedure on the same anatomic location.

- Undergoing other vascular procedures during the same surgical session (applies to vascular surgery [IG1202-A] only; stenting and/or endarterectomy of the same artery are allowed).

- Undergone a therapeutic surgical procedure within 30 days from screening (diagnostic procedures are allowed).

- Previously included in this trial (i.e. each subject can only be enrolled once in this study).

- TBS cannot be identified according to the investigator's judgment.

- TBS has a severe bleeding according to the Investigator's judgment.

- Occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure.

- Application of any topical haemostatic material on the resection surface of the liver prior to application of the study treatment (applies to hepatic surgery [IG1202-B] only).

- Radiofrequency precoagulation of the liver resection surface, except focal use of radiofrequency as primary haemostatic treatment (applies to hepatic surgery [IG1202-B] only).

- Intra-operative change in planned surgical procedure which results in subject no longer meeting preoperative inclusion and/or exclusion criteria.

- Application of any topical haemostatic material on the cut soft tissue surface prior to application of the study treatment (applies to soft tissue surgery [IG1202-C] only).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
Human thrombin
Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin
Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges

Locations

Country Name City State
United States 905 Baltimore Maryland
United States 803 Boulder Colorado
United States 508 Chapel Hill North Carolina
United States 604 Evanston Illinois
United States 503 Ft. Worth Texas
United States 507 Gainesville Florida
United States 908 Hartford Connecticut
United States 900 Houston Texas
United States 902 Jackson Mississippi
United States 501, 901 Jacksonville Florida
United States 800 Las Vegas Nevada
United States 804 Lexington Kentucky
United States 602 Los Angeles California
United States 600 New York New York
United States 700, 801 Pasadena California
United States 606 Poughkeepsie New York
United States 605 Salt Lake City Utah
United States 802 Spokane Washington
United States 805 Tucson Arizona
United States 601 Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Instituto Grifols, S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subjects achieving hemostasis at the TBS Hemostasis at the TBS defined by 'Yes" or "No" response (by Investigator) without the occurrence of re-bleeding through the completion of surgical closure. 5 minutes following the start of treatment application No
Primary Treatment-emergent adverse events Treatment-emergent adverse events defined as adverse events (including suspected adverse reactions) occurring after the start of treatment until 30 (+/- 4) days post-surgery. Start of treatment application through post-operative Day 30 Yes
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