Liver CirrhosisNCT00816127
Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction
A study testing Desmopressin and blood transfusion in people with Liver Cirrhosis and Coagulopathy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Coagulopathy
- What is being tested?
- Desmopressin and blood transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to May 2007
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: Intranasal DDAVP in Preventing Bleeding During Dental Extraction in Cirrhotic Patients
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.
Read the 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.
- Conditions
- Liver Cirrhosis, Coagulopathy
- Being tested
- Desmopressin, blood transfusion
- Keywords
- liver cirrhosis, coagulopathy, desmopressin, blood transfusion
- Medical subject headings
- Liver Cirrhosis, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
intranasal desmopressin (300μg)
blood transfusionBiological
fresh frozen plasma 10ml/kg and/or 1 unit of single donor platelets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | DDAVP Receives: Drug: Desmopressin |
| 2 | Active comparator | Standard Treatment Receives: Biological: blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Necessity of rescue blood transfusion in patients who received DDAVP or blood transfusion prior to dental extraction.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startOct 2003
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Investigators
- Thomas D. Schiano, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816127
- Sponsor's protocol ID
- 02-0727
- Status last verified
- Dec 2008
- First submitted
- 29 Dec 2008
- Last updated
- 1 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11928081Kobrinsky 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.
PubMed 6144876de 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.
PubMed 3923887Mannucci 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.
PubMed 6401193Saulnier 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.
PubMed 8108099Mannucci 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.
PubMed 67283Mannucci PM. Desmopressin (DDAVP) in the treatment of bleeding disorders: the first 20 years. Blood. 1997 Oct 1;90(7):2515-21. No abstract available.
PubMed 9326215