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Are all the participating systems in the Denver area?

GG

In a message dated 5/13/2004 11:41:32 PM Central Daylight Time,

jimmnn@... writes:

>Denver Health System is currently doing a PolyHeme study. EMS will randomly

>start either NS or PolyHeme in the field in selected patients. Here's the

>link to the page:

>

It's actually a multi-center pre hospital trial Gene and we here in

Denver are only 1 of about 20 systems participating.

Jim<

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Guest guest

>Denver Health System is currently doing a PolyHeme study. EMS will randomly

>start either NS or PolyHeme in the field in selected patients. Here's the

>link to the page:

>

It's actually a multi-center pre hospital trial Gene and we here in

Denver are only 1 of about 20 systems participating.

Jim<

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Share on other sites

Guest guest

>Denver Health System is currently doing a PolyHeme study. EMS will randomly

>start either NS or PolyHeme in the field in selected patients. Here's the

>link to the page:

>

It's actually a multi-center pre hospital trial Gene and we here in

Denver are only 1 of about 20 systems participating.

Jim<

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Guest guest

>Are all the participating systems in the Denver area?

No just Denver Health and Hospitals which is Denver city and county.

The surround 30 some that operate under the Denver Metro Protocols

are not involved.

Jim<

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Guest guest

>Are all the participating systems in the Denver area?

No just Denver Health and Hospitals which is Denver city and county.

The surround 30 some that operate under the Denver Metro Protocols

are not involved.

Jim<

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Guest guest

I think this is the current study.

Jack

http://www.clinicaltrials.gov/ct/show/NCT00076648?order=1

Safety and Efficacy of PolyHeme® in Hemorrhagic Shock Following Traumatic

Injuries Beginning in the Pre-Hospital Setting

This study is currently recruiting patients.

Sponsored by

Northfield Laboratories

Purpose

This study is designed to assess the survival benefit of administering

PolyHeme to severely injured trauma patients in hemorrhagic shock beginning

in the prehospital setting, where blood is not available, and continuing

throughout a 12-hour postinjury hospital setting.

Condition Treatment or Intervention Phase

Hemorrhagic Shock

Drug: Poly SFH-P Injection

Phase III

MedlinePlus related topics: First Aid/Emergencies

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment,

Safety/Efficacy Study

Official Title: A Phase III, Randomized, Controlled, Open-Label,

Multicenter, Parallel Group Study Using Provisions for Exception from

Informed Consent Requirements Designed to Evaluate the Safety and Efficacy

of Poly SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated),

PolyHeme®] When Used to Treat Patients in Hemorrhagic Shock Following

Traumatic Injuries Beginning in the Prehospital Setting

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study:

Both

Criteria

Inclusion Criteria:

Adult patients following trauma who have sustained blood loss and are in

shock

Exclusion Criteria:

Patients who have sustained unsurvivable injuries

Patients who have severe head injury

Pregnant females

Patients found in cardiac arrest

Patients who object to participation (e.g., religious grounds, wearing

exclusion bracelet).

Location and Contact Information

Colorado

Denver Health Medical Center, Denver, Colorado, 80204, United

States; Recruiting

S Long, RRT

Delaware

Christiana Hospital, Newark, Delaware, 19718, United States;

Recruiting

Babenko, RN

Ohio

MetroHealth Medical Center, Cleveland, Ohio, 44109, United States;

Recruiting

Carolyn , RN

Pennsylvania

Lehigh Valley Hospital, town, Pennsylvania, 18103, United

States; Recruiting

Sabella, RN

Tennessee

University of Tennessee-Memphis, Memphis, Tennessee, 38163, United

States; Recruiting

Panzer, RN

Texas

Memorial-Hermann Hospital, Houston, Texas, 77030, United States;

Recruiting

Belanie Peavy-Abbs, RN

More Information

Study ID Numbers RTBSE-11-(N)

Record last reviewed April 2004

NLM Identifier NCT00076648

ClinicalTrials.gov processed this record on 2004-05-14

Re: PolyHeme Study

Are all the participating systems in the Denver area?

GG

In a message dated 5/13/2004 11:41:32 PM Central Daylight Time,

jimmnn@... writes:

>Denver Health System is currently doing a PolyHeme study. EMS will

>randomly start either NS or PolyHeme in the field in selected patients.

>Here's the link to the page:

>

It's actually a multi-center pre hospital trial Gene and we here in Denver

are only 1 of about 20 systems participating.

Jim<

Link to comment
Share on other sites

Guest guest

I think this is the current study.

Jack

http://www.clinicaltrials.gov/ct/show/NCT00076648?order=1

Safety and Efficacy of PolyHeme® in Hemorrhagic Shock Following Traumatic

Injuries Beginning in the Pre-Hospital Setting

This study is currently recruiting patients.

Sponsored by

Northfield Laboratories

Purpose

This study is designed to assess the survival benefit of administering

PolyHeme to severely injured trauma patients in hemorrhagic shock beginning

in the prehospital setting, where blood is not available, and continuing

throughout a 12-hour postinjury hospital setting.

Condition Treatment or Intervention Phase

Hemorrhagic Shock

Drug: Poly SFH-P Injection

Phase III

MedlinePlus related topics: First Aid/Emergencies

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment,

Safety/Efficacy Study

Official Title: A Phase III, Randomized, Controlled, Open-Label,

Multicenter, Parallel Group Study Using Provisions for Exception from

Informed Consent Requirements Designed to Evaluate the Safety and Efficacy

of Poly SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated),

PolyHeme®] When Used to Treat Patients in Hemorrhagic Shock Following

Traumatic Injuries Beginning in the Prehospital Setting

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study:

Both

Criteria

Inclusion Criteria:

Adult patients following trauma who have sustained blood loss and are in

shock

Exclusion Criteria:

Patients who have sustained unsurvivable injuries

Patients who have severe head injury

Pregnant females

Patients found in cardiac arrest

Patients who object to participation (e.g., religious grounds, wearing

exclusion bracelet).

Location and Contact Information

Colorado

Denver Health Medical Center, Denver, Colorado, 80204, United

States; Recruiting

S Long, RRT

Delaware

Christiana Hospital, Newark, Delaware, 19718, United States;

Recruiting

Babenko, RN

Ohio

MetroHealth Medical Center, Cleveland, Ohio, 44109, United States;

Recruiting

Carolyn , RN

Pennsylvania

Lehigh Valley Hospital, town, Pennsylvania, 18103, United

States; Recruiting

Sabella, RN

Tennessee

University of Tennessee-Memphis, Memphis, Tennessee, 38163, United

States; Recruiting

Panzer, RN

Texas

Memorial-Hermann Hospital, Houston, Texas, 77030, United States;

Recruiting

Belanie Peavy-Abbs, RN

More Information

Study ID Numbers RTBSE-11-(N)

Record last reviewed April 2004

NLM Identifier NCT00076648

ClinicalTrials.gov processed this record on 2004-05-14

Re: PolyHeme Study

Are all the participating systems in the Denver area?

GG

In a message dated 5/13/2004 11:41:32 PM Central Daylight Time,

jimmnn@... writes:

>Denver Health System is currently doing a PolyHeme study. EMS will

>randomly start either NS or PolyHeme in the field in selected patients.

>Here's the link to the page:

>

It's actually a multi-center pre hospital trial Gene and we here in Denver

are only 1 of about 20 systems participating.

Jim<

Link to comment
Share on other sites

Guest guest

I think this is the current study.

Jack

http://www.clinicaltrials.gov/ct/show/NCT00076648?order=1

Safety and Efficacy of PolyHeme® in Hemorrhagic Shock Following Traumatic

Injuries Beginning in the Pre-Hospital Setting

This study is currently recruiting patients.

Sponsored by

Northfield Laboratories

Purpose

This study is designed to assess the survival benefit of administering

PolyHeme to severely injured trauma patients in hemorrhagic shock beginning

in the prehospital setting, where blood is not available, and continuing

throughout a 12-hour postinjury hospital setting.

Condition Treatment or Intervention Phase

Hemorrhagic Shock

Drug: Poly SFH-P Injection

Phase III

MedlinePlus related topics: First Aid/Emergencies

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment,

Safety/Efficacy Study

Official Title: A Phase III, Randomized, Controlled, Open-Label,

Multicenter, Parallel Group Study Using Provisions for Exception from

Informed Consent Requirements Designed to Evaluate the Safety and Efficacy

of Poly SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated),

PolyHeme®] When Used to Treat Patients in Hemorrhagic Shock Following

Traumatic Injuries Beginning in the Prehospital Setting

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study:

Both

Criteria

Inclusion Criteria:

Adult patients following trauma who have sustained blood loss and are in

shock

Exclusion Criteria:

Patients who have sustained unsurvivable injuries

Patients who have severe head injury

Pregnant females

Patients found in cardiac arrest

Patients who object to participation (e.g., religious grounds, wearing

exclusion bracelet).

Location and Contact Information

Colorado

Denver Health Medical Center, Denver, Colorado, 80204, United

States; Recruiting

S Long, RRT

Delaware

Christiana Hospital, Newark, Delaware, 19718, United States;

Recruiting

Babenko, RN

Ohio

MetroHealth Medical Center, Cleveland, Ohio, 44109, United States;

Recruiting

Carolyn , RN

Pennsylvania

Lehigh Valley Hospital, town, Pennsylvania, 18103, United

States; Recruiting

Sabella, RN

Tennessee

University of Tennessee-Memphis, Memphis, Tennessee, 38163, United

States; Recruiting

Panzer, RN

Texas

Memorial-Hermann Hospital, Houston, Texas, 77030, United States;

Recruiting

Belanie Peavy-Abbs, RN

More Information

Study ID Numbers RTBSE-11-(N)

Record last reviewed April 2004

NLM Identifier NCT00076648

ClinicalTrials.gov processed this record on 2004-05-14

Re: PolyHeme Study

Are all the participating systems in the Denver area?

GG

In a message dated 5/13/2004 11:41:32 PM Central Daylight Time,

jimmnn@... writes:

>Denver Health System is currently doing a PolyHeme study. EMS will

>randomly start either NS or PolyHeme in the field in selected patients.

>Here's the link to the page:

>

It's actually a multi-center pre hospital trial Gene and we here in Denver

are only 1 of about 20 systems participating.

Jim<

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