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Trial · Interventional

CompletedNot applicableRegistry data

Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction

NCTNCT00816127 (opens ClinicalTrials.gov in a new tab)Other id02-0727
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
36 participants (actual)
Sponsor
Icahn School of Medicine at Mount Sinai · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Oct 2003
Primary completion
May 2007
Completion
May 2007
First posted
31 Dec 2008 (estimated)
Last update posted
1 Jan 2009 (estimated)
Conditions
Liver Cirrhosis · Coagulopathy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200320042005200620072008
  1. N/A

    Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction

    NCT00816127

    Oct 2003 to May 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DesmopressinDrug
  • blood transfusionBiological

Arms2

  • Experimental

    1

    DDAVP

  • Active comparator

    2

    Standard Treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 48 hours

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 1977

9 results

1-Deamino-8-d-arginine vasopressin: a new pharmacological approach to the management of haemophilia and von Willebrands' diseases.

Mannucci et al. 1977Lancet (London, England)cited by 372

PMID 67283DOI 10.1016/s0140-6736(77)91197-7PUB-00067283

Full text at the publisher9 results
Publisher pageSee results (9)

More studies

4 studies on this page

PubMed tag: none · 1994

Evaluation of desmopressin for dental extractions in patients with hemostatic disorders.

Saulnier et al. 1994Oral surgery, oral medicine, and oral pathologycited by 12

PMID 8108099DOI 10.1016/s0030-4220(06)80099-xPUB-08108099

Full text at the publisher
Publisher page

PubMed tag: none · 1985

Response of patients with mild and moderate hemophilia A and von Willebrand's disease to treatment with desmopressin.

de la Fuente et al. 1985Annals of internal medicinecited by 98

PMID 3923887DOI 10.7326/0003-4819-103-1-6PUB-03923887

Full text at the publisher
Publisher page

PubMed tag: none · 1984

Shortening of bleeding time by 1-deamino-8-D-arginine vasopressin in various bleeding disorders.

Kobrinsky et al. 1984Lancet (London, England)cited by 123

PMID 6144876DOI 10.1016/s0140-6736(84)91393-xPUB-06144876

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 1983

Deamino-8-D-arginine vasopressin shortens the bleeding time in uremia.

Mannucci et al. 1983The New England journal of medicinecited by 325

PMID 6401193DOI 10.1056/nejm198301063080102PUB-06401193

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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