Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00816127
Recruitment Status : Completed
First Posted : December 31, 2008
Last Update Posted : January 1, 2009
Information provided by:
Icahn School of Medicine at Mount Sinai

Brief Summary:
The purpose of this study is to investigate how effective and cost saving 1-deamino-8-D-arginine vasopressin (desmopressin, DDAVP) is as opposed to the transfusion of blood products in preventing bleeding after teeth extraction in persons with severe liver disease being evaluated for liver transplant.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Coagulopathy Drug: Desmopressin Biological: blood transfusion Not Applicable

Detailed Description:
Liver cirrhosis is associated with dysregulation of the coagulation system resulting in an increased bleeding tendency in cirrhotic patients. The treatment approach to offset these abnormalities may involve transfusion with fresh frozen plasma (FFP) and platelets. Fluid overload may become a concern as the large amount of FFP (10-20mls/kg or >1,500ml) required to achieve the hemostatic effect could be contraindicated in some patients. Furthermore, repeated platelet transfusion induces alloimmunization and refractoriness to new transfusion, which is an important issue in patients on the waiting list for liver transplantation in which HLA-matched and cross-matched platelets may be required. Non-transfusional drugs that help to stop bleeding have been used in patients with congenital bleeding disorders. 1-deamino-8-D-arginine vasopressin (DDAVP, Desmopressin), a synthetic analogue of the antidiuretic hormone, L-arginine, has been used as a non-transfusional form of replacement therapy in a variety of congenital and acquired bleeding disorders. Through unknown mechanisms, DDAVP shortens the prolonged bleeding times of cirrhotic patients despite the high plasma concentrations of Factor VIII and von Willebrand factor sound in chronic liver disease, indicating that it might be useful as a prophylactic treatment in cirrhotic patients undergoing minimally invasive procedures, i.e. dental extraction.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intranasal DDAVP in Preventing Bleeding During Dental Extraction in Cirrhotic Patients
Study Start Date : October 2003
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Arm Intervention/treatment
Experimental: 1
Drug: Desmopressin
intranasal desmopressin (300μg)

Active Comparator: 2
Standard Treatment
Biological: blood transfusion
fresh frozen plasma 10ml/kg and/or 1 unit of single donor platelets

Primary Outcome Measures :
  1. Necessity of rescue blood transfusion in patients who received DDAVP or blood transfusion prior to dental extraction. [ Time Frame: 48 hours ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients with biopsy-proven liver cirrhosis or clinical/radiological evidence of cirrhosis, requiring dental extraction
  • platelet count of 30,000-50,000/microL and/or INR 2.0-3.0

Exclusion Criteria:

  • the presence of other bleeding disorders besides cirrhosis such as renal dysfunction (creatinine > 2.0) or HIV
  • receipt of blood transfusion within 2 weeks prior to study
  • recent acute decompensation of liver cirrhosis
  • malignancy excluding hepatocellular carcinoma in the absence of portal vein thrombosis
  • treatment with anti-platelet medications (aspirin, non-steroidal anti-inflammatory drugs or clopidogrel) within ten days prior to the extraction
  • documented allergy to DDAVP.

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 identifier (NCT number): NCT00816127

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Principal Investigator: Thomas D. Schiano, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Thomas D. Schiano, M.D, Mount Sinai School of Medicine Identifier: NCT00816127     History of Changes
Other Study ID Numbers: 02-0727
First Posted: December 31, 2008    Key Record Dates
Last Update Posted: January 1, 2009
Last Verified: December 2008

Keywords provided by Icahn School of Medicine at Mount Sinai:
liver cirrhosis
blood transfusion

Additional relevant MeSH terms:
Liver Cirrhosis
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Deamino Arginine Vasopressin
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs