Desmopressin for Bleeding Related to Low Body Temperature | NCT00902057

Studies
Desmopressin for Bleeding Related to Low Body Temperature

NCT00902057

Sponsor

The University of Hong Kong

Status

Unknown status

Last Update Posted

May 14, 2009Estimated

Enrollment

48Estimated

Phase

Phase 4

Conditions

Hypothermia Induced Impairment of Primary Haemostasis

Interventions

desmopressin
desmopressin
desmopressin
placebo

Countries

China

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

May 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2010Estimated

Completion Date

Jun 2011Estimated

First Submitted Date

May 13, 2009

First Submission Date that Met QC Criteria

May 13, 2009

First Posted Date

May 14, 2009Estimated

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

May 13, 2009

Last Update Posted Date

May 14, 2009Estimated

Description Module

Brief Summary

To study, with a prospective randomised controlled design, whether the subcutaneous administration of the haemostatic drug desmopressin, may improve the impairment of primary haemostasis due to mildly decreased temperature.

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
desmopressin 1.5	Active Comparator	Drug: desmopressin
desmopressin 3	Active Comparator	Drug: desmopressin
desmopressin 15	Active Comparator	Drug: desmopressin
placebo	Placebo Comparator	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
desmopressin	Drug	single desmopressin subcutaneous injection, 1.5mcg	desmopressin 1.5

Measure	Description	Time Frame
closure time on PFA-100		3 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Healthy volunteers

Exclusion Criteria:

Any known platelet or coagulation disorder.
Pregnant or lactating women.
Known chronic liver or renal disease.
Coronary artery, carotid artery or peripheral artery disease
Recent history of taking antiplatelet drugs, anticoagulants or herbal preparations.
Smoker or alcohol user
Mentally incapable of providing informed consent
Students or junior staff members who had direct working relationship with the PI

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kwok F.J. Ng, MBChB, MD, MBA, FANZCA, FHKAM	Contact	(852) 28553303		jkfng@hku.hk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Hong Kong		Hong Kong	Hong Kong	HKSAR	China

Intervention Browse Module

MeSH Terms

ID	Term
D003894	Deamino Arginine Vasopressin

Ancestor Terms

ID	Term
D001127	Arginine Vasopressin
D014667	Vasopressins
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones

Browse Leaves

Not provided

Browse Branches

Not provided