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Desmopressin for Bleeding Related to Low Body Temperature

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ClinicalTrials.gov Identifier: NCT00902057
Recruitment Status : Unknown
Verified May 2009 by The University of Hong Kong.
Recruitment status was:  Not yet recruiting
First Posted : May 14, 2009
Last Update Posted : May 14, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Hypothermia Induced Impairment of Primary Haemostasis Drug: desmopressin Drug: placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Desmopressin on Platelet Dysfunction Associated With Mild Hypothermia in Healthy Volunteers
Study Start Date : June 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: desmopressin 1.5 Drug: desmopressin
single desmopressin subcutaneous injection, 1.5mcg
Active Comparator: desmopressin 3 Drug: desmopressin
single desmopressin subcutaneous injection, 3mcg
Active Comparator: desmopressin 15 Drug: desmopressin
single desmopressin subcutaneous injection, 15mcg
Placebo Comparator: placebo Drug: placebo
saline subcutaneous


Outcome Measures

Primary Outcome Measures :
  1. closure time on PFA-100 [ Time Frame: 3 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1. Healthy volunteers

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902057


Contacts
Contact: Kwok F.J. Ng, MBChB, MD, MBA, FANZCA, FHKAM (852) 28553303 jkfng@hku.hk

Locations
China, Hong Kong
The University of Hong Kong Not yet recruiting
Hong Kong, Hong Kong, China, HKSAR
Contact: Kwok F.J. Ng, MBChB, MD, FANZCA, FHKAM, MBA    (852) 28553303    jkfng@hku.hk   
Principal Investigator: Kwok F. J. Ng, MD,MBA         
Sponsors and Collaborators
The University of Hong Kong
More Information

Responsible Party: Dr Kwok Fu Jacobus Ng, Department of Anaesthesiology, the Univeristy of Hong Kong
ClinicalTrials.gov Identifier: NCT00902057     History of Changes
Other Study ID Numbers: UW 09-088
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: May 14, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs