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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
  Purpose

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 Intervention
Liver Cirrhosis
Coagulopathy
Drug: Desmopressin
Biological: blood transfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intranasal DDAVP in Preventing Bleeding During Dental Extraction in Cirrhotic Patients

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: October 2003
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
DDAVP
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816127

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Thomas D. Schiano, MD Mount Sinai School of Medicine
  More Information

Publications:
Responsible Party: Thomas D. Schiano, M.D, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00816127     History of Changes
Other Study ID Numbers: 02-0727
Study First Received: December 29, 2008
Last Updated: December 31, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
liver cirrhosis
coagulopathy
desmopressin
blood transfusion

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Liver Cirrhosis
Cardiovascular Diseases
Digestive System Diseases
Hematologic Diseases
Hemorrhagic Disorders
Liver Diseases
Vascular Diseases
Deamino Arginine Vasopressin
Antidiuretic Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014