Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction
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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 |
- 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 |
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| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| 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 Hemorrhage Liver Cirrhosis Fibrosis Hematologic Diseases Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders Pathologic Processes Liver Diseases |
Digestive System Diseases Deamino Arginine Vasopressin Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 17, 2013