Status:

COMPLETED

Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction

Lead Sponsor:

Icahn School of Medicine at Mount Sinai

Conditions:

Liver Cirrhosis

Coagulopathy

Eligibility:

All Genders

18+ years

Phase:

NA

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 blee...

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 i...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2007

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT00816127

Start Date

October 1 2003

End Date

May 1 2007

Last Update

January 1 2009

Active Locations (1)

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Mount Sinai School of Medicine

New York, New York, United States, 10029