NCT00371215

CompletedPhase 2

Study of Recombinant Human Thrombin for Bleeding During Auto...

ZymoGenetics Source

ZymoGenetics

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

499E02

Study Type

interventional

Actual enrollment (reported)

72

Locations

1 country

Sites

1

Timeline

Study Start

August 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2007

Actual (reported)

Study Completion

June 2007

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 72 participants
Study completion date: June 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 30, 2006
Actual (reported)
First Posted
September 1, 2006
Actual (reported)
Primary Completion
June 2007
Actual (reported)
Study Completion
June 2007
Actual (reported)

Last Updated: March 9, 2009
Status Verified: March 2009
Last Update Submitted: March 6, 2009

Conditions

Surgical Hemostasis

Keywords

hemostasisgrafting, skinhemostaticsphase 2

Outcome Measures

Primary Outcomes (1)

The incidence and severity of adverse events
Up to day 29

Secondary Outcomes (5)

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
Up to 20 minutes
The percentage of graft take
Up to day 29
The incidence of re-grafting
Up to day 29

Study Arms (1)

1

EXPERIMENTAL

rThrombin

Biological: rThrombin

Interventions

rThrombinBiological

1000 U/mL applied topically

1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age2 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

ZymoGenetics
Industrylead

Study Sites (1)

Richard M. Fairbanks Burn Center, Wishard Hospital

Indianapolis, Indiana, 46202, United States

MeSH Terms

Interventions

recombinant human thrombin

Study Officials

Allan Alexander, MD
ZymoGenetics
STUDY DIRECTOR

Enrollment

72 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

August 30, 2006

First Posted

September 1, 2006

Study Start

August 2006

Date type not reported

This date has not been verified as actual or estimated.

NCT07013955

Comparative Study Between the Effect of Dexmedetomidine ,Midazolam or Bupivacaine Packing During FESS on Surgical Field Visualization

Phase 3Enrolling By Invitation

Known antibodies or hypersensitivity to thrombin or other coagulation factors

Contact the study team to confirm eligibility.

Primary Completion

June 2007

Actual (reported)

Study Completion

June 2007

Actual (reported)

Last Updated

March 9, 2009

Record last verified: 2009-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00371215
Data provider: ClinicalTrials.gov
Source updated: 2009-03-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:20 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations