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

December 29, 2008
December 31, 2008
January 1, 2009
October 2003
May 2007   (Final data collection date for primary outcome measure)
Necessity of rescue blood transfusion in patients who received DDAVP or blood transfusion prior to dental extraction. [ Time Frame: 48 hours ]
Same as current
Complete list of historical versions of study NCT00816127 on Archive Site
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Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction
Intranasal DDAVP in Preventing Bleeding During Dental Extraction in Cirrhotic Patients
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Liver Cirrhosis
  • Coagulopathy
  • Drug: Desmopressin
    intranasal desmopressin (300μg)
  • Biological: blood transfusion
    fresh frozen plasma 10ml/kg and/or 1 unit of single donor platelets
  • Experimental: 1
    Intervention: Drug: Desmopressin
  • Active Comparator: 2
    Standard Treatment
    Intervention: Biological: blood transfusion

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2007
May 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Thomas D. Schiano, M.D, Mount Sinai School of Medicine
Icahn School of Medicine at Mount Sinai
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Principal Investigator: Thomas D. Schiano, MD Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP