Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction
Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Cirrhosis; Coagulopathy
Intervention: Desmopressin (Drug); blood transfusion (Biological)
Phase: N/A
Status: Completed
Sponsored by: Icahn School of Medicine at Mount Sinai Official(s) and/or principal investigator(s): Thomas D. Schiano, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai
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.
Clinical Details
Official title: Intranasal DDAVP in Preventing Bleeding During Dental Extraction in Cirrhotic Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Necessity of rescue blood transfusion in patients who received DDAVP or blood transfusion prior to dental extraction.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Mount Sinai School of Medicine, New York, New York 10029, United States
Additional Information
Related publications: Amitrano L, Guardascione MA, Brancaccio V, Balzano A. Coagulation disorders in liver disease. Semin Liver Dis. 2002 Feb;22(1):83-96. Review. Kobrinsky NL, Israels ED, Gerrard JM, Cheang MS, Watson CM, Bishop AJ, Schroeder ML. Shortening of bleeding time by 1-deamino-8-D-arginine vasopressin in various bleeding disorders. Lancet. 1984 May 26;1(8387):1145-8. de la Fuente B, Kasper CK, Rickles FR, Hoyer LW. Response of patients with mild and moderate hemophilia A and von Willebrand's disease to treatment with desmopressin. Ann Intern Med. 1985 Jul;103(1):6-14. Mannucci PM, Remuzzi G, Pusineri F, Lombardi R, Valsecchi C, Mecca G, Zimmerman TS. Deamino-8-D-arginine vasopressin shortens the bleeding time in uremia. N Engl J Med. 1983 Jan 6;308(1):8-12. Saulnier J, Marey A, Horellou MH, Goudemand J, Lepoutre F, Donazzan M, Gazengel C, Torchet M, Letang C, Schuhmann C, et al. Evaluation of desmopressin for dental extractions in patients with hemostatic disorders. Oral Surg Oral Med Oral Pathol. 1994 Jan;77(1):6-12. Mannucci PM, Ruggeri ZM, Pareti FI, Capitanio A. 1-Deamino-8-d-arginine vasopressin: a new pharmacological approach to the management of haemophilia and von Willebrands' diseases. Lancet. 1977 Apr 23;1(8017):869-72. Mannucci PM. Desmopressin (DDAVP) in the treatment of bleeding disorders: the first 20 years. Blood. 1997 Oct 1;90(7):2515-21. Review.
Starting date: October 2003
Last updated: December 31, 2008
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