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Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction

This study has been completed.
Sponsor:
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00816127
First received: December 29, 2008
Last updated: December 31, 2008
Last verified: December 2008

December 29, 2008
December 31, 2008
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00816127 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
    DDAVP
    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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00816127
02-0727
No
Thomas D. Schiano, M.D, Mount Sinai School of Medicine
Mount Sinai School of Medicine
Not Provided
Principal Investigator: Thomas D. Schiano, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
December 2008

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