Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction

NCT00816127 | Completed

• 1 other identifier: 02-0727
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Coagulopathy

Keywords

liver cirrhosis; coagulopathy; desmopressin; blood transfusion

Outcome Measures

Primary Outcomes (1)

• Necessity of rescue blood transfusion in patients who received DDAVP or blood transfusion prior to dental extraction.

  48 hours

Study Arms (2)

1

EXPERIMENTAL

DDAVP

Drug: Desmopressin

2

ACTIVE COMPARATOR

Standard Treatment

Biological: blood transfusion

Interventions

Desmopressin DRUG

intranasal desmopressin (300μg)

1

blood transfusion BIOLOGICAL

fresh frozen plasma 10ml/kg and/or 1 unit of single donor platelets

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (7)

• Amitrano L, Guardascione MA, Brancaccio V, Balzano A. Coagulation disorders in liver disease. Semin Liver Dis. 2002 Feb;22(1):83-96. doi: 10.1055/s-2002-23205.

  PMID: 11928081 BACKGROUND

• 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. doi: 10.1016/s0140-6736(84)91393-x.

  PMID: 6144876 BACKGROUND

• 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. doi: 10.7326/0003-4819-103-1-6.

  PMID: 3923887 BACKGROUND

• 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. doi: 10.1056/NEJM198301063080102.

  PMID: 6401193 BACKGROUND

• 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. doi: 10.1016/s0030-4220(06)80099-x.

  PMID: 8108099 BACKGROUND

• 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. doi: 10.1016/s0140-6736(77)91197-7.

  PMID: 67283 BACKGROUND

• Mannucci PM. Desmopressin (DDAVP) in the treatment of bleeding disorders: the first 20 years. Blood. 1997 Oct 1;90(7):2515-21. No abstract available.

  PMID: 9326215 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Hemostatic Disorders

Interventions

Deamino Arginine Vasopressin; Blood Transfusion

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Biological Therapy; Therapeutics

Study Officials

• Thomas D. Schiano, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2008
• First Posted: December 31, 2008
• Study Start: October 1, 2003
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: January 1, 2009

Record last verified: 2008-12

Locations

US (1)