Study of Recombinant Human Thrombin for Bleeding During A... | NCT00371215

Studies
Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting

NCT00371215

Sponsor

ZymoGenetics

Status

Completed

Last Update Posted

Mar 9, 2009Estimated

Enrollment

72Actual

Phase

Phase 2

Conditions

Surgical Hemostasis

Interventions

rThrombin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Aug 30, 2006

First Submission Date that Met QC Criteria

Aug 30, 2006

First Posted Date

Sep 1, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2009

Last Update Posted Date

Mar 9, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.

Detailed Description

This is a Phase 2 multiple site, single-arm, open-label study designed to evaluate the safety of rThrombin in subjects of age 2 to 75 years who are receiving a partial- or full-thickness autologous sheet or mesh grafts following burn or traumatic skin injury. After establishing eligibility, study participants will be treated with topical spray rThrombin at the skin graft recipient site during autologous skin graft surgery. There will be a 1-month follow-up period after the surgery.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	rThrombin	Biological: rThrombin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rThrombin	Biological	1000 U/mL applied topically	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence and severity of adverse events		Up to day 29

Secondary Outcomes

Measure	Description	Time Frame
The incidence and grade of clinical laboratory abnormalities		Up to day 29
The incidence of anti-rThrombin product antibodies		Up to day 29
The incidence of hemostasis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Autologous skin grafting with sheet or mesh grafts following burn or traumatic skin injury

Exclusion Criteria:

Known antibodies or hypersensitivity to thrombin or other coagulation factors

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allan Alexander, MD	ZymoGenetics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Richard M. Fairbanks Burn Center, Wishard Hospital		Indianapolis	Indiana	46202	United States

Intervention Browse Module

MeSH Terms

ID	Term
C513462	recombinant human thrombin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided