Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction

Not Applicable

Completed

• Conditions: Liver Cirrhosis; Coagulopathy
• Interventions: Drug: Desmopressin; Biological: blood transfusion

• Registration Number: NCT00816127
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-10
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2008-12
• Study First Submitted: 2008-12-29
• Study First Submitted QC: 2008-12-30
• Study First Posted: 2008-12-31
• Last Update Submitted: 2008-12-31
• Last Update Posted: 2009-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Desmopressin	DDAVP
2	blood transfusion	Standard Treatment

Primary Outcome Measures

Name	Time	Method
Necessity of rescue blood transfusion in patients who received DDAVP or blood transfusion prior to dental extraction.	48 hours

Trial Locations

Locations (1)

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States