NCT00733434

Brief Summary

Prostaglandin E1 (PGE1 )has been shown to have vasodilatation and anti-thrombosis effects, so it is used by some surgeons after microsurgery to keep the patency of the anastomosed small vessels. However, PGE 1 may also causes some complications, like pleural effusion or deep vein thrombosis. Therefore, it remains uncertain whether a routine use of PGE 1 after head and neck microsurgery is justified. We aim to test the hypothesis that PGE 1 increases postoperative vessel patency rate in patients undergoing head and neck microsurgery, with a comparable complication rate as the control group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
242

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

October 27, 2009

Status Verified

October 1, 2009

Enrollment Period

1 year

First QC Date

August 12, 2008

Last Update Submit

October 26, 2009

Conditions

MicrosurgeryHead and NeckProstaglandin E1ThrombosisComplications

Keywords

MicrosurgeryHead and neckProstaglandin E1ThrombosisComplication

Outcome Measures

Primary Outcomes (1)

  • Free flap re-exploration rate

    7 days after microsurgery

Secondary Outcomes (1)

  • Surgical complication rate

    hospitalization period

Study Arms (2)

1

EXPERIMENTAL

Patients receiving PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days

Drug: Prostaglandin E1

2

PLACEBO COMPARATOR

Patients receiving 500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days

Other: Saline

Interventions

Prostaglandin E1DRUG

PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days

Also known as: Alprostadil, Promostan
1
SalineOTHER

500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days

Also known as: Normal saline
2

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring microvascular reconstruction after head and neck cancer resection

You may not qualify if:

  • Patients with coagulation dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (6)

  • Disa JJ, Polvora VP, Pusic AL, Singh B, Cordeiro PG. Dextran-related complications in head and neck microsurgery: do the benefits outweigh the risks? A prospective randomized analysis. Plast Reconstr Surg. 2003 Nov;112(6):1534-9. doi: 10.1097/01.PRS.0000083378.58757.54.

    PMID: 14578781BACKGROUND

  • Rodriguez Vegas JM, Ruiz Alonso ME, Teran Saavedra PP. PGE-1 in replantation and free tissue transfer: early preliminary experience. Microsurgery. 2007;27(5):395-7. doi: 10.1002/micr.20377.

    PMID: 17596843BACKGROUND

  • Ashjian P, Chen CM, Pusic A, Disa JJ, Cordeiro PG, Mehrara BJ. The effect of postoperative anticoagulation on microvascular thrombosis. Ann Plast Surg. 2007 Jul;59(1):36-9; discussion 39-40. doi: 10.1097/01.sap.0000264837.15110.2f.

    PMID: 17589257BACKGROUND

  • Watanabe H, Anayama S, Horiuchi T, Sato E, Hamada Y, Ishihara H. Pleural effusion caused by prostaglandin E1 preparation. Chest. 2003 Mar;123(3):952-3. doi: 10.1378/chest.123.3.952.

    PMID: 12628901BACKGROUND

  • Barthelmes L, Chezhian C, Aihaku EK. Deep venous thrombosis and venous thrombophlebitis associated with alprostadil treatment for erectile dysfunction. Int J Impot Res. 2002 Jun;14(3):199-200. doi: 10.1038/sj.ijir.3900853.

    PMID: 12058249BACKGROUND

  • Lee KS, Suh JD, Han SB, Yoo JC, Lee SJ, Cho SJ. The effect of aspirin and prostaglandin E(1) on the patency of microvascular anastomosis in the rats. Hand Surg. 2001 Dec;6(2):177-85. doi: 10.1142/s0218810401000643.

    PMID: 11901464BACKGROUND

MeSH Terms

Conditions

Thrombosis

Interventions

AlprostadilSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, MonounsaturatedAutacoidsInflammation MediatorsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Yueh-Bih Tang, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueh-Bih Tang, MD, PhD

CONTACT

886-2-23123456phoebetang@ntu.edu.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 12, 2008

First Posted

August 13, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2010

Last Updated

October 27, 2009

Record last verified: 2009-10

Locations

TW(1)