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Desmopressin for Bleeding Related to Low Body Temperature

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by The University of Hong Kong.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00902057
First received: May 13, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention Phase
Hypothermia Induced Impairment of Primary Haemostasis
 Drug: desmopressin
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Desmopressin on Platelet Dysfunction Associated With Mild Hypothermia in Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • closure time on PFA-100 [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: June 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 13, 2009
Last Updated: May 13, 2009
Health Authority: Hong Kong: Ethics Committee

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

ClinicalTrials.gov processed this record on May 19, 2013